EP2651364A1 - Systeme, verfahren und vorrichtung zur abgabe von nervenstimulierungen an einen patienten unter ärztlicher aufsicht - Google Patents

Systeme, verfahren und vorrichtung zur abgabe von nervenstimulierungen an einen patienten unter ärztlicher aufsicht

Info

Publication number
EP2651364A1
EP2651364A1 EP11849125.7A EP11849125A EP2651364A1 EP 2651364 A1 EP2651364 A1 EP 2651364A1 EP 11849125 A EP11849125 A EP 11849125A EP 2651364 A1 EP2651364 A1 EP 2651364A1
Authority
EP
European Patent Office
Prior art keywords
patient
vestibular stimulation
waveform
physician
prescription
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
EP11849125.7A
Other languages
English (en)
French (fr)
Other versions
EP2651364A4 (de
Inventor
Lesco L. Rogers
Lanty L. Smith
Robert D. Black
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Scion Neurostim Inc
Original Assignee
Scion Neurostim Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US12/970,347 external-priority patent/US8603152B2/en
Application filed by Scion Neurostim Inc filed Critical Scion Neurostim Inc
Publication of EP2651364A1 publication Critical patent/EP2651364A1/de
Publication of EP2651364A4 publication Critical patent/EP2651364A4/de
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/12—Devices for heating or cooling internal body cavities
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/007—Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00—Magnetotherapy
    • A61N2/002—Magnetotherapy in combination with another treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00—Magnetotherapy
    • A61N2/004—Magnetotherapy specially adapted for a specific therapy
    • A61N2/006—Magnetotherapy specially adapted for a specific therapy for magnetic stimulation of nerve tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00875—Resistance or impedance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0001—Body part
    • A61F2007/0002—Head or parts thereof
    • A61F2007/0005—Ears
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/007—Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating
    • A61F2007/0075—Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating using a Peltier element, e.g. near the spot to be heated or cooled
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0093—Heating or cooling appliances for medical or therapeutic treatment of the human body programmed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0095—Heating or cooling appliances for medical or therapeutic treatment of the human body with a temperature indicator
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0095—Heating or cooling appliances for medical or therapeutic treatment of the human body with a temperature indicator
    • A61F2007/0096—Heating or cooling appliances for medical or therapeutic treatment of the human body with a temperature indicator with a thermometer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02—Compresses or poultices for effecting heating or cooling
    • A61F2007/0295—Compresses or poultices for effecting heating or cooling for heating or cooling or use at more than one temperature
    • A61F2007/0296—Intervals of heating alternated with intervals of cooling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36036—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of the outer, middle or inner ear

Definitions

  • the present invention concerns apparatuses and associated methods useful for delivering stimulation to the vestibular system and/or the nervous system of an individual, thereby inducing physiological changes in the individual and/or treating a disorder or symptom of the individual.
  • Caloric vestibular stimulation has been widely and safely utilized for more than a century for diagnostic purposes, particularly in the emergency room to detect brain function after injury and in ear, nose and throat practice to assess balance.
  • CVS activates the sensory organs of the vestibular system located within the inner ear.
  • the core elements consist of the semi-circular canals, which sense rotational motion, and the otoliths, which sense linear acceleration. Motion within the semi-circular canals is detected through motion of internal fluid (endolymph), which in turn activates hair cells that generate electrical signals, which are then transmitted via the 8th cranial nerve to the brainstem and widely throughout the cerebellum and cortical regions.
  • irrigation of the external auditory canal (the ear canal) with warm or cold water/air changes the density of the endolymph in the semi-circular canal of the inner ear, which in turn activates the pathways noted above. Nystagmus, or the vestibulo-ocular reflex, is an easily observed result of CVS, wherein the eyes move spontaneously, even if the patient is unconscious.
  • vestibular stimulation is also known to release important neurotransmitters (e.g., serotonin, acetylcholine, histamine, endorphins, vasopressin and dopamine) (Fu-rong et al., CHIN. MED. J. 120(2):120-124 (2007); Horii et al., J. NEUROPHYSIOL. 72:605-61 1 (1994); Tabet, AGE AND AGING 35 :336-338 (2006); Horii et al., J. NEUROPHYSIOL. 70: 1822-1826 (1993); Horii et al., BRAIN RES. 914: 179-184 (2001)).
  • important neurotransmitters e.g., serotonin, acetylcholine, histamine, endorphins, vasopressin and dopamine
  • CVS appears to have an advantage: although nystagmus habituates with repetition of CVS (Naito et al., BRAIN 126 (2003), the vestibular neurological response appears not to be patient to such habituation or accommodation. (Emani-Nouri, ACTA OTOLARYNGOLOGICA 76: 183-189 (1973)).
  • CVS does not have the same potential for side effects like a drug. Yet, CVS has not attained wide-spread use for therapeutic purposes. Hence, there remains a need for new ways to carry out CVS for therapeutic purposes.
  • a first aspect of the present invention is a vestibular stimulation device for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • the vestibular stimulation device comprises, consists essentially of or consists of an earpiece, a thermoelectric device (TED) and a controller, wherein said TED is thermally coupled to said earpiece and wherein said controller is operatively connected to said TED and is configured to activate said TED to deliver one or more thermal waveforms to the vestibular system and /or the nervous system of a patient (i.e., to activate the TED such that the earpiece is warmed and/or cooled so as to deliver the thermal waveform(s) to the vestibular system and/or the nervous system of the patient).
  • TED thermoelectric device
  • the vestibular stimulation device further comprises a heat sink
  • the TED is thermally coupled between the earpiece and the heat sink such that activation of the TED facilitates the transfer or heat between the earpiece and the heat sink.
  • the controller is configured to generate a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient and to activate the TED to deliver the prescribed thermal waveform(s).
  • a second aspect of the present invention is a physician control device for generating and/or modifying the parameters, indications and/or approvals of one of more thermal waveforms; for generating, modifying, updating and/or extending one or more prescriptions and/or for receiving, analyzing and/or transmitting data.
  • the physician control device is configured to generate and/or modify the parameters, indications and/or approvals of one or more idealized thermal waveforms.
  • the physician control device is configured to generate a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • the physician control device is configured to transmit the parameters, indications and/or approvals of one or more thermal waveforms to one or more vestibular stimulation devices and/or one or more patient control devices. In some embodiments, the physician control device is configured to transmit one or more prescriptions to one or more vestibular stimulation devices and/or one or more patient control devices. In some embodiments, the physician control device is configured to receive data from one or more vestibular stimulation devices and/or one or more patient control devices. In some embodiments, the physician control device is configured to transmit data to one or more physician support devices.
  • a third aspect of the present invention is a patient control device for receiving, analyzing and or transmitting data.
  • the patient control device is configured to receive the parameters, indications and/or approvals of one or more thermal waveforms from a physician control device.
  • the patient control device is configured to transmit the parameters, indications and/or approvals of one or more thermal waveforms to one or more vestibular stimulation devices.
  • the patient control device is configured to receive a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient from a physician control device.
  • the patient control device is configured to transmit a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient to a vestibular stimulation device.
  • the patient control device is configured to receive data from one or more vestibular stimulation devices.
  • the physician control device is configured to transmit data to one or more physician control devices.
  • a fourth aspect of the present invention is a physician support device for generating and/or modifying the parameters, indications and/or approvals of one of more thermal waveforms; for generating, modifying, updating and/or extending one or more prescriptions and/or for receiving, analyzing and/or transmitting data.
  • the physician support device is configured to generate and/or modify the parameters, indications and/or approvals of one or more idealized thermal waveforms.
  • the physician support device is configured to generate a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • the physician support device is configured to transmit the parameters, indications and/or approvals of one or more thermal waveforms to one or more vestibular stimulation devices, one or more patient control devices and/or one or more physician control devices. In some embodiments, the physician support device is configured to transmit one or more prescriptions to one or more vestibular stimulation devices, one or more patient control devices and/or one or more physician control devices. In some embodiments, the physician support device is configured to receive data from one or more vestibular stimulation devices, one or more patient control devices and/or one or more physician control devices.
  • a fifth aspect of the present invention is a registry for receiving, storing and/or transmitting data.
  • the registry is configured to receive data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g., idealized thermal waveforms) from one or more vestibular stimulation devices, one or more patient control devices, one or more physician control devices and/or one or more physician support devices.
  • the registry is configured to transmit data associated the parameters, indications and/or approvals of one of more idealized thermal waveforms to one or more vestibular stimulation devices, one or more patient control devices, one or more physician control devices and/or one or more physician support devices.
  • a sixth aspect of the present invention is a telemedicine module for facilitating and/or controlling communications between vestibular stimulation devices, patient control devices, physician control devices and/or physician support devices.
  • the telemedicine module is configured to facilitate and/or control communications between a vestibular stimulation device, ad patient control device, a physician control device and/or a physician support device by ensuring that data is transmitted between the devices in a manner that complies with any and all applicable laws and/or regulations (e.g. , the Health Insurance Portability and Accountability Act of 1996 (P.L. 104-191 ; " ⁇ ")).
  • a seventh aspect of the present invention is a vestibular stimulation system for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • the vestibular stimulation system comprises a physician control device configured to generate a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient and a vestibular stimulation device configured to deliver the prescribed thermal waveforms to the patient.
  • An eighth aspect of the present invention is a method of delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • the method comprises generating a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient and delivering the prescribed thermal waveform(s) to the patient using a vestibular stimulation device.
  • a ninth aspect of the present invention is a method of updating a waveform database.
  • the method comprises analyzing physician feedback data and modifying one or more thermal waveforms in the waveform database responsive to analyzing the physician feedback data.
  • Figure 1 is a block diagram of a vestibular stimulation device according to some embodiments of the present invention.
  • Figures 2-12 are screenshots illustrating various functionalities of a controller according to some embodiments of the present invention, wherein the controller comprises an interactive touchscreen.
  • Figure 2 depicts a startup screen wherein the current time is shown in the upper right-hand corner of the screen.
  • Figures 3 depicts a waveform module screen wherein the user has generated a thermal waveform by drawing the desired waveform on the interactive touch screen and wherein the waveform module has identified fourteen waveform modulation points (gray diamonds).
  • Figure 4 depicts a waveform module screen wherein the thermal waveform depicted in Figure 3 has been modified by selecting the third waveform modulation point of the thermal waveform and moving it to a higher temperature.
  • Figure 5 depicts a treatment module screen that enables a user to provide instructions as to how many days are to be in a treatment schedule and how many treatments may be administered per day.
  • Figure 6 depicts a treatment module screen that enables a user to authorize delivery of one or more prescribed thermal waveform(s) during one or more specified time periods by touching an available treatment window (represented by a grey rectangle with a black dash in its center) and then providing instructions as to which thermal waveform(s) is/are to be delivered during that treatment window (as shown in Figures 7-8) and instructions as to when the treatment window is to begin and end (as shown in Figure 9).
  • Figure 7 depicts a treatment module screen that enables a user to provide instructions to apply an idealized thermal waveform to the ear canal of a patient by touching the circular selection indicator to the right of the desired waveform.
  • Figure 8 depicts a treatment module screen that enables a user to provide instructions to apply the selected thermal waveform to the left or right ear canal of a patient by touching the upper or lower graph, respectively.
  • Figure 9 depicts a treatment module screen that enables a user to provide instructions as to when a given treatment window is to begin and end (i.e., to provide instructions as to the window of time in which one or more prescribed thermal waveforms may be administered to a patient).
  • Figure 10 depicts a treatment module screen that enables a user to modify a treatment schedule by editing and/or copying previously established treatment sessions (e.g. , by changing which thermal waveform(s) are to be delivered during a given treatment session (as shown in Figures 7-8), by changing the start and/or end time for one or more treatment sessions (as shown in Figure 9), by deleting one or more treatment sessions, etc.).
  • a treatment schedule by editing and/or copying previously established treatment sessions (e.g. , by changing which thermal waveform(s) are to be delivered during a given treatment session (as shown in Figures 7-8), by changing the start and/or end time for one or more treatment sessions (as shown in Figure 9), by deleting one or more treatment sessions, etc.).
  • Figure 11 depicts a control module screen wherein a thermal waveform delivered to the left ear canal and a thermal waveform being delivered to the right ear canal of a patient are graphically represented, with the current progress of each waveform represented by the changing of the depicted waveform from light gray to dark grey (i.e., the elapsed time is represented by the dark gray portion of each waveform and the time remaining is represented by the light gray portion of each waveform), and wherein the user may stop the treatment session by touching the "X" in the lower left-hand corner of the screen.
  • Figure 12 depicts a password protection screen.
  • Figure 13 is a block diagram of a controller according to some embodiments of the present invention.
  • Figure 14 is a block diagram of a controller according to some embodiments of the present invention.
  • Figure 15 is a block diagram of a controller according to some embodiments of the present invention.
  • Figure 16 is an illustration of a controller according to some embodiments of the present invention.
  • Figure 17 is an illustration of a controller according to some embodiments of the present invention.
  • Figure 18A is a perspective view of an earpiece according to some embodiments of the present invention.
  • Figure 18B is a side view of an earpiece according to some embodiments of the present invention.
  • Figure 18C is a cross-sectional view of an earpiece according to some embodiments of the present invention.
  • Figure 19 is a perspective view of a vestibular stimulation device according to some embodiments of the present invention.
  • Figure 20 is an exploded view of a vestibular stimulation device headset housing according to some embodiments of the present invention.
  • Figure 21A is an exploded, perspective view of an earpiece, a TED and a heat sink according to some embodiments of the present invention.
  • Figure 21B is an exploded, cross-sectional view of an earpiece, a TED, a spacer and a heat sink according to some embodiments of the present invention.
  • Figure 22 is a block diagram of a physician control device according to some embodiments of the present invention.
  • Figure 23 is a block diagram of a physician control device according to some embodiments of the present invention.
  • Figure 24 is a block diagram of a physician control device according to some embodiments of the present invention.
  • Figure 25 is a block diagram of a patient control device according to some embodiments of the present invention.
  • Figure 26 is a block diagram of a patient control device according to some embodiments of the present invention.
  • Figure 27 is a block diagram of a patient control device according to some embodiments of the present invention.
  • Figure 28 is a block diagram of a physician support device according to some embodiments of the present invention.
  • Figure 29 is a block diagram of a physician support device according to some embodiments of the present invention.
  • Figure 30 is a block diagram of a physician support device according to some embodiments of the present invention.
  • Figure 31 is a block diagram of a registry according to some embodiments of the present invention.
  • Figure 32 is a block diagram of a registry according to some embodiments of the present invention.
  • Figure 33 is a block diagram of a vestibular stimulation system according to some embodiments of the present invention comprising a vestibular stimulation device and a physician control device.
  • Figure 34 is a block diagram of a vestibular stimulation system according to some embodiments of the present invention comprising a physician control device and a plurality of vestibular stimulation devices.
  • Figure 35 is a block diagram of a vestibular stimulation system according to some embodiments of the present invention comprising a vestibular stimulation device and a physician control device.
  • Figure 36 is a block diagram of a vestibular stimulation system according to some embodiments of the present invention comprising a vestibular stimulation device, a patient control device and a physician control device.
  • Figure 37 is a block diagram of a vestibular stimulation system according to some embodiments of the present invention comprising a physician control device, a plurality of patient control devices and a plurality of vestibular stimulation devices.
  • Figure 38 is a block diagram of a vestibular stimulation system according to some embodiments of the present invention comprising a vestibular stimulation device, a patient control device and a physician control device.
  • Figure 39 is a block diagram of a vestibular stimulation system according to some embodiments of the present invention comprising a vestibular stimulation device, a physician control device and a physician support device.
  • Figure 40 is a block diagram of a vestibular stimulation system according to some embodiments of the present invention comprising a physician support device, a plurality of physician control devices and a plurality of vestibular stimulation devices.
  • Figure 41 is a block diagram of a vestibular stimulation system according to some embodiments of the present invention comprising a vestibular stimulation device, a physician control device and a physician support device.
  • Figure 42 is a block diagram of a vestibular stimulation system according to some embodiments of the present invention comprising a vestibular stimulation device, a physician control device, a physician support device and a registry.
  • Figure 43 is a block diagram of a vestibular stimulation system according to some embodiments of the present invention comprising a registry, a plurality of physician control devices and a plurality of vestibular stimulation devices.
  • Figure 44 is a block diagram of a vestibular stimulation system according to some embodiments of the present invention comprising a vestibular stimulation device, a physician control device and a registry.
  • Figure 45 is a block diagram illustrating a method of delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient according to some embodiments of the present invention.
  • Figure 46 is a block diagram illustrating a method of delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient according to some embodiments of the present invention.
  • FIGS 47A 47F are schematic diagrams of various non-limiting examples of thermal waveforms that may be delivered using the devices, systems and methods of the present invention. While each line A through F illustrates several cycles of a given frequency and waveform shape, note that "waveform” herein generally refers to a single cycle of a given frequency and waveform shape.
  • the computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture including instructions which implement the function/act specified in the block diagram and/or flowchart illustrations.
  • the computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable data processing apparatus to produce a computer- implemented process such that the instructions which execute on the computer or other programmable data processing apparatus provide steps for implementing the functions/acts specified in the block diagrams and/or flowchart illustrations.
  • the present invention may be embodied in hardware and/or software (including firmware, resident software, micro-code, etc.).
  • embodiments of the present invention may take the form of a computer program product on a computer-usable or computer-readable non-transient storage medium having computer-usable or computer-readable program code embodied in the medium for use by or in connection with an instruction execution system.
  • a computer usable or computer-readable non- transient storage medium may be any medium that can contain and/or store the program for use by or in connection with the instruction execution system, apparatus or device.
  • the computer-usable or computer-readable medium may be an electronic, optical, electromagnetic, infrared or semiconductor system, apparatus or device.
  • the terms “actively controlled waveform” and “actively controlled, time-varying thermal waveform” refer to a thermal waveform in which the intensity and/or the directionality of the activation signal used to deliver the thermal waveform and/or the temperature of the earpiece used to deliver the thermal waveform is repeatedly adjusted (e.g., continuously adjusted or substantially continuously adjusted) during delivery of the thermal waveform.
  • the activation signal driving the TED(s) used to deliver the thermal waveform may be continuously adjusted in response to feedback data from one or more sensors (e.g., a temperature sensor configured to sense the temperature of the earpiece with which the TED(s) is/are associated).
  • Such active control may be used to minimize errors in the delivery of a prescribed thermal waveform (e.g., by minimizing thermal drift, which may otherwise allow the patient's body temperature to adversely affect the accuracy).
  • the term "adjuvant treatment” refers to a treatment session in which the delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of a patient modifies the effect(s) of one or more active agents and/or therapies.
  • the delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of a patient may enhance the effectiveness of a pharmaceutical agent (by restoring the therapeutic efficacy of a drug to which the patient had previously become habituated, for example).
  • the delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of a patient may enhance the effectiveness of counseling or psychotherapy.
  • delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of a patient may reduce or eliminate the need for one or more active agents and/or therapies.
  • Adjuvant treatments may be effectuated by delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient prior to, currently with and/or after administration of one or more active agents and/or therapies.
  • chronic treatment refers to a therapeutic treatment carried out at least once per week (e.g., two or three times per week, daily, etc.) over an extended period of time.
  • Chronic treatment typically lasts at least one to two weeks (and, in some embodiments, at least one to two months), but may last as long as required to achieve and/or maintain therapeutic efficacy for the particular condition or disorder for which the treatment is carried out (i.e., the device may be used periodically throughout the patient's life).
  • controller feedback data refers to data that is transmitted to the controller by one or more TEDs and/or one or more sensors and is used by the controller to verify the accuracy of the thermal waveform(s) being delivered, to modulate the activation of one or more TEDs so as to deliver the appropriate thermal waveform(s) and/or to enable the controller to activate safety precautions in the event of a system failure.
  • controller feedback data may comprise data associated with the temperature of an earpiece, wherein said data is used to verify that the appropriate temperature is being delivered to the ear canal of a patient, to enable the controller to increase/decrease the activation of one or more TEDs to ensure that the appropriate temperature is delivered to the ear canal of a patient and/or to trigger a system shutdown if the temperature of the earpiece drops below a low temperature threshold (e.g., about 10 degrees Centigrade) or exceeds a high temperature threshold (e.g. , about 50 degrees Centigrade).
  • a low temperature threshold e.g., about 10 degrees Centigrade
  • a high temperature threshold e.g. , about 50 degrees Centigrade
  • controller feedback data may comprise data associated with the temperature of a heat sink that is thermally coupled to one or more TEDs, wherein said data is used to trigger a system shutdown if the temperature of the heat sink exceeds a high temperature threshold (e.g., about 50 degrees Centigrade).
  • a high temperature threshold e.g., about 50 degrees Centigrade
  • the term "data associated with the delivery of one or more thermal waveforms” refers to information associated with the delivery of one or more thermal waveforms and may include, but is not limited to, data associated with the target time/temperature parameters of the thermal waveform(s), the time/temperature parameters of the thermal waveform(s) delivered; the date/time of delivery of the thermal waveform(s), the temperature of the patient's ear canal(s) at various time points before, during and/or after delivery of the thermal waveform(s); the temperature of the patient's inner ear(s) at various time points before, during and/or after delivery of the thermal waveform(s); the fit of the earpiece(s) at various time points before, during and/or after delivery of the thermal waveform(s); an estimate of the thermal contact between the earpiece(s) and the patient's ear canal(s) at various time points before, during and/or after delivery of the thermal waveform(s); patient-specific time constants (e.g., a time constant associated with
  • thermal waveform(s) how long it took for the patient to react to the thermal waveform(s)); effectiveness of the thermal waveform(s) (e.g., whether and to what extent symptoms were relieved, whether the thermal waveform(s) enhanced the effectiveness of another agent/therapy, etc.); stability of the treatment (i.e.
  • data associated with the delivery of one or more thermal waveforms comprises controller feedback data, patient feedback data and/or physician feedback data.
  • data associated with the delivery of one or more thermal waveforms comprises, consists essentially of or consists of data associated with the precise time/temperature parameters of the thermal waveform(s) delivered to the patient and a subjective measure of efficacy (e.g., a patient-reported pain score).
  • data associated with the fit of the earpiece(s) may include, but is not limited to, data associated with the impedance between an earpiece inserted into the ear canal of a patient and an electrode affixed to a second location on/in said patient's body (e.g.
  • an electrode placed in or adjacent to the patient's other ear canal data associated with the rate at which the ear canal and/or the inner ear cooled in response to a cooling stimulus (e.g., data from a temperature sensor, such as thermistor, that monitors how quickly the ear canal and/or the inner ear cools in response to a cooling waveform), data associated with the rate at which the ear canal and/or the inner ear warmed in response to a warming stimulus (e.g., data from a temperature sensor, such as a thermistor, that monitors how quickly the ear canal and/or the inner ear warms in response to a warming waveform) and patient comments regarding the subjective fit of the earpiece(s).
  • a cooling stimulus e.g., data from a temperature sensor, such as thermistor, that monitors how quickly the ear canal and/or the inner ear cools in response to a cooling waveform
  • a warming stimulus e.g., data from a temperature sensor, such as
  • data associated with the fit of the earpiece(s) comprises, consists essentially or consists of data associated with the impedance between an earpiece inserted into the right ear canal of a patient and an earpiece inserted into the left ear canal of said patient.
  • the terms "idealized thermal waveform” and “idealized waveform” refer to a thermal waveform that has been indicated and/or approved for use in the treatment of one or more diseases/disorders/injuries and/or for use in the provision of neuroprotection, enhanced cognition and/or increased cognitive reserve.
  • a thermal waveform may be indicated for use in the treatment of migraines if it has effectively treated migraines in the past or if it belongs to a class of thermal waveforms that are known to treat migraines.
  • a thermal waveform may be approved for use in the treatment of a given disorder if it has received regulatory approval (e.g. FDA approval) for such use, or if it belongs to a class of thermal waveforms that have been approved for the treatment of that disorder.
  • An idealized thermal waveform may be indicated/approved for use in the treatment of multiple diseases/disorders/injuries.
  • the term "patient” refers to both human subjects and animal subjects, including, but not limited to, mice, rats, rabbits, cats, dogs, pigs, horses, monkeys, apes, etc.
  • the patient may be male or female. That patient may be of any suitable age, including infant, juvenile, adolescent, adult and geriatric ages.
  • the methods, devices and systems of the present invention may be used to induce physiological and/or psychological responses in a patient for medically diagnostic and/or therapeutic purposes.
  • the methods, devices and systems of the present invention may be used to diagnose and/or treat mammalian subjects, such as mice, rats, pigs and monkeys, for medical research or veterinary purposes.
  • patient information refers to data associated with one or more patients.
  • Patient information may comprise, but is not limited to, information related to a patient's identity, a patient's cognitive abilities, a patient's medical history, a patient's current symptoms (if any), a patient's present diagnosis (if any), a patient's current prescriptions (if any) and data associated with the delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • patient feedback data refers to data associated with patient feedback regarding the delivery of one or more thermal waveforms.
  • Patient feedback data may comprise, but is not limited to, a patient's evaluation of their pain level before, during and/or after delivery of the thermal waveform(s) (e.g., patient- reported pain scores given before, during and after a treatment session) and patient comments (e.g. , comments regarding a patient's opinion as to the efficacy of a given waveform or the effect(s) of certain waveform modifications, etc.).
  • physician feedback data refers to data associated with physician feedback regarding the delivery of one or more thermal waveforms.
  • Physician feedback data may comprise, but is not limited to, patient information from the patient history database of one or more physician control devices and comments from one or more physicians (e.g., comments regarding a physician's opinion as to the efficacy of a given waveform or the effect(s) of certain waveform modifications, etc.).
  • a prescription comprises, consists essentially of or consists of a set of instructions for delivering of one or more thermal waveforms (e.g. , one or more actively controlled, time-varying thermal waveforms) to the vestibular system and/or the nervous system of a patient (e.g. , by warming and/or cooling an earpiece positioned in the ear canal of the patient).
  • one or more thermal waveforms e.g. , one or more actively controlled, time-varying thermal waveforms
  • a prescription may comprise a set of instructions for delivering one or more thermal waveforms to the left vestibular system of a patient (by delivering one or more thermal waveforms to the left ear canal of the patient) and/or a set of instructions for delivering one or more thermal waveforms to the right vestibular system of a patient (by delivering one or more thermal waveforms to the left ear canal of the patient) (i.e., one prescription may comprise instructions for stimulating both the right and left vestibular systems).
  • a prescription may comprise any suitable instructions and/or limitations, including, but not limited to, the parameters of the waveform(s) to be delivered to the patient, the number and frequency of treatment sessions (e.g., X treatment sessions over Y time period), a limitation as to how many treatment sessions may be administered during a given time period (e.g., no more than X treatment sessions within Y time period), instructions as to which thermal waveform(s) will be administered during a given treatment session (and in what order they are to be administered), instructions as to which vestibular system will receive a given waveform (e.g., right, left or both) and an expiration date.
  • the parameters of the waveform(s) to be delivered to the patient e.g., the number and frequency of treatment sessions (e.g., X treatment sessions over Y time period), a limitation as to how many treatment sessions may be administered during a given time period (e.g., no more than X treatment sessions within Y time period), instructions as to which thermal waveform(s) will be administered
  • a prescription comprises instructions for delivering a placebo (i.e., for fooling a patient into believing one or more thermal waveforms has been delivered even though no such deliver has occurred).
  • the prescription is generated by a physician. Any conventional security means may be provided to prevent unauthorized modification of the prescription (e.g., the prescription may be password protected, with only the prescribing physician having knowledge of and/or access to the password).
  • treatment refers to reversing, alleviating, reducing the severity of, delaying the onset of, inhibiting the progress of or preventing a disease or disorder as described herein, or at least one symptom of a disease or disorder as described herein (e.g., treating one or more of tremors, bradykinesia, rigidity or postural instability associated with Parkinson's disease; treating one or more of intrusive symptoms (e.g., dissociative states, flashbacks, intrusive emotions, intrusive memories, nightmares, and night terrors), avoidant symptoms (e.g., avoiding emotions, avoiding relationships, avoiding responsibility for others, avoiding situations pronounced of the traumatic event) or hyperarousal symptoms (e.g., exaggerated startle reaction, explosive outbursts, extreme vigilance, irritability, panic symptoms, sleep disturbance) associated with posttraumatic stress disorder).
  • intrusive symptoms e.g., dissociative states, flashbacks, intrusive emotions, intrusive memories,
  • treatment may be administered after one or more symptoms have developed. In other embodiments, treatment may be administered in the absence of symptoms. For example, treatment may be administered to a susceptible individual prior to the onset of symptoms (e.g. , in light of a history of symptoms and/or in light of genetic or other susceptibility factors). Treatment may also be continued after symptoms have resolved— for example, to prevent or delay their recurrence. Treatment may comprise providing neuroprotection, enhancing cognition and/or increasing cognitive reserve. Treatment may be as an adjuvant treatment as further described herein.
  • the present invention may be used to treat a patient for any reason.
  • the present invention is used to treat one or more disorders.
  • Disorders for which treatment may be carried out include, but are not limited to, headaches, depression, anxiety (e.g. , as experienced in post-traumatic stress disorder ("PTSD") or other anxiety disorders), dementia, spatial neglect, Parkinson's disease, seizures (e.g., epileptic seizures) and diabetes (e.g. , type II diabetes).
  • Additional disorders and conditions that can be treated by the methods and systems of the present invention include, but are not limited to, tinnitus, neuropathic pain (e.g., migraine headaches), brain injury (acute brain injury, excitotoxic brain injury, traumatic brain injury, etc.), spinal cord injury, body image or integrity disorders (e.g., spatial neglect), visual intrusive imagery, neuropsychiatric disorders (e.g., depression), bipolar disorder, neurodegenerative disorders (e.g., Parkinson's disease), asthma, dementia, insomnia, stroke, cellular ischemia, metabolic disorders, (e.g., diabetes), PTSD, addictive disorders, sensory disorders, motor disorders, and cognitive disorders.
  • neuropathic pain e.g., migraine headaches
  • brain injury acute brain injury, excitotoxic brain injury, traumatic brain injury, etc.
  • spinal cord injury body image or integrity disorders (e.g., spatial neglect), visual intrusive imagery
  • neuropsychiatric disorders e.g., depression
  • bipolar disorder e.g
  • Headaches that may be treated by the methods and apparatuses of the present invention include, but are not limited to, primary headaches (e.g., migraine headaches, tension-type headaches, trigeminal autonomic cephalagias and other primary headaches, such as cough headaches and exertional headaches) and secondary headaches. See, e.g. , International Headache Society Classification ICHD-II.
  • Migraine headaches that may be treated by the methods and apparatuses of the present invention may be acute/episodic/chronic and unilateral/bilateral.
  • the migraine headache may be of any type, including, but not limited to, migraine with aura, migraine without aura, hemiplegic migraine, opthalmoplegic migraine, retinal migraine, basilar artery migraine, abdominal migraine, vestibular migraine and probable migraine.
  • vesibular migraine refers to migraine with associated vestibular symptoms, including, but not limited to, head motion intolerance, unsteadiness, dizziness and vertigo.
  • Vestibular migraine includes, but is not limited to, those conditions sometimes referred to as vertigo with migraine, migraine-associated dizziness, migraine-related vestibulopathy, migrainous vertigo and migraine-related vertigo. See, e.g., Teggi et al., HEADACHE 49:435-444 (2009).
  • Tension-type headaches that may be treated by the methods and apparatuses of the present invention, include, but are not limited to, infrequent episodic tension-type headaches, frequent episodic tension-type headaches, chronic tension-type headache and probable tension-type headache.
  • Trigeminal autonomic cephalagias that may be treated by the methods and apparatuses of the present invention, include, but are not limited to, cluster headaches, paroxysmal hemicranias, short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing and probable trigeminal autonomic cephalagias.
  • Cluster headache sometimes referred to as "suicide headache,” is considered different from migraine headache.
  • Cluster headache is a neurological disease that involves, as its most prominent feature, an immense degree of pain.
  • Cluster refers to the tendency of these headaches to occur periodically, with active periods interrupted by spontaneous remissions. The cause of the disease is currently unknown.
  • Cluster headaches affect approximately 0.1% of the population, and men are more commonly affected than women (in contrast to migraine headache, where women are more commonly affected than men).
  • primary headaches that may be treated by the methods and apparatuses of the present invention, include, but are not limited to, primary cough headache, primary exertional headache, primary headache associated with sexual activity, hypnic headache, primary thunderclap headache, hemicranias continua and new daily- persistent headache.
  • Sensory disorders that may be treated by the methods and apparatuses of the present invention include, but are not limited to, vertigo, dizziness, seasickness, travel sickness cybersickness, sensory processing disorder, hyperacusis, fibromyalgia, neuropathic pain (including, but not limited to, complex regional pain syndrome, phantom limb pain, thalamic pain syndrome, craniofacial pain, cranial neuropathy, autonomic neuropathy, and peripheral neuropathy (including, but not limited to, entrapment-, heredityT, acute inflammatory-, diabetes-, alcoholism-, industrial toxin-, Leprosy-, Epstein Barr Virus-, liver disease-, ischemia-, and
  • Motor disorders that may be treated by the method and apparatuses of the present invention include, but are not limited to, upper motor neuron disorders such as spastic paraplegia, lower motor neuron disorders such as spinal muscular atrophy and bulbar palsy, combined upper and lower motor neuron syndromes such as familial amyotrophic lateral sclerosis and primary lateral sclerosis, and movement disorders (including, but not limited to, Parkinson's disease, tremor, dystonia, Tourette Syndrome, myoclonus, chorea, nystagmus, spasticity, agraphia, dysgraphia, alien limb syndrome, and drug-induced movement disorders).
  • upper motor neuron disorders such as spastic paraplegia
  • lower motor neuron disorders such as spinal muscular atrophy and bulbar palsy
  • combined upper and lower motor neuron syndromes such as familial amyotrophic lateral sclerosis and primary lateral sclerosis
  • movement disorders including, but not limited to, Parkinson's disease, tremor, dystonia, Tourette Syndrome
  • Cognitive disorders that may be treated by the method and apparatuses of the present invention include, but are not limited to, schizophrenia, addiction, anxiety disorders, depression, bipolar disorder, dementia, insomnia, narcolepsy, autism, Alzheimer's disease, anomia, aphasia, dysphasia, parosmia, spatial neglect, attention deficit hyperactivity disorder, obsessive compulsive disorder, eating disorders, body image disorders, body integrity disorders, post-traumatic stress disorder, intrusive imagery disorders, and mutism.
  • Metabolic disorders that may be treated by the present invention include diabetes (particularly type ⁇ diabetes), hypertension, obesity, etc.
  • Addiction addictive disorders, or addictive behavior that may be treated by the present invention includes, but is not limited to, alcohol addiction, tobacco or nicotine addiction (e.g., using the present invention as a smoking cessation aid), drug addictions (e.g., opiates, oxycontin, amphetamines, etc.), food addictions (compulsive eating disorders), etc.
  • drug addictions e.g., opiates, oxycontin, amphetamines, etc.
  • food addictions compact eating disorders
  • the patient has two or more of the above conditions, and both conditions are treated concurrently with the methods and systems of the invention.
  • a patient with both depression and anxiety e.g., PTSD
  • vestibular system has the meaning ascribed to it in the medical arts and includes, but is not limited to, those portions of the inner ear known as the vestibular apparatus and the vestibulocochlear nerve.
  • the vestibular system therefore, further includes, but is not limited to, those parts of the brain that process signals from the vestibulocochlear nerve.
  • waveform As used herein, the terms “waveform,” “waveform stimulus” and “thermal waveform” refer to a thermal stimulus (heating and/or cooling) delivered to the ear canal of a patient. "Waveform” is not to be confused with “frequency,” the latter term concerning the rate of delivery of a particular waveform.
  • waveform is used herein to refer to one complete cycle thereof, unless additional cycles (of the same, or different, waveform) are indicated. As discussed further below, time-varying thermal waveforms are preferred over square waveforms in carrying out the present invention.
  • a waveform of the present invention comprises a leading edge, a peak, and a trailing edge.
  • the waveform leading edge is preferably ramped or time-varying: that is, the amplitude of the waveform increases through a plurality of different temperature points over time (e.g., at least 5, 10, or 15 or more distinct temperature points, and in some embodiments at least 50, 100, or 150 or more distinct temperature points, from start to peak).
  • the shape of the leading edge may be a linear ramp, a curved ramp (e.g., convex or concave; logarithmic or exponential), or a combination thereof.
  • a vertical cut may be included in the waveform leading edge, so long as the remaining portion of the leading edge progresses through a plurality of different temperature points over time as noted above.
  • the peak of the waveform represents the amplitude of the waveform as compared to the patient's body temperature. In general, an amplitude of at least 5 or 7 degrees Centigrade is preferred for both heating and cooling waveform stimulation. In general, an amplitude of up to 25 degrees Centigrade is preferred for cooling waveform stimulation (e.g., 15 degrees Centigrade). In general, an amplitude of up to 8 or 10 degrees Centigrade is preferred for heating waveform stimulus (e.g., 6 degrees Centigrade).
  • the peak of the waveform may be truncated (that is, the waveform may reach an extended temperature plateau), as long as the desired characteristics of the leading edge, and preferably trailing edge, are retained. For heating waveforms, truncated peaks of long duration (that is, maximum heat for a long duration) are less preferred, particularly at higher heats, because of the potential that the patient may experience a burning sensation.
  • the waveform trailing edge is preferably ramped or time-varying: that is, the amplitude of the waveform decreases through a plurality of different temperature points over time (e.g., at least 5, 10, or 15 or more distinct temperature points, or in some embodiments at least 50, 100, or 150 or more distinct temperature points, from peak to trough).
  • the shape of the trailing edge may be a linear ramp, a curved ramp (e.g., convex or concave; logarithmic or exponential), or a combination thereof.
  • a vertical cut may again be included in the waveform trailing edge, as long as the remaining portion of the trailing edge progresses through a plurality of different temperature points over time as noted above.
  • the duration of a waveform is the time from the onset of the leading edge to either the conclusion of the trailing edge or (in the case of a vertically cut waveform) the onset of a subsequent waveform.
  • each waveform has a duration, or frequency, of from one or two minutes up to ten or twenty minutes.
  • the minimal stimulus point therebetween i.e. , the point of minimal heating or minimal cooling
  • the trough may be truncated, as long as the desired characteristics of the trailing edge and the following leading edge are retained. While the trough may represent a return to the patient's current body temperature, in some embodiments minor thermal stimulation (e.g., cooling or heating by 1 or 2 degrees up to 4 or 5 degrees Centigrade) may continue to be applied at the trough (or through a truncated trough).
  • minor thermal stimulation e.g., cooling or heating by 1 or 2 degrees up to 4 or 5 degrees Centigrade
  • a plurality of waveforms may be delivered in sequence.
  • a treatment session will comprise 1, 2 or 3 waveforms, up to about 10 or 20 or more waveforms delivered sequentially.
  • Each individual waveform may be the same, or different, from the other waveform(s).
  • the first waveform of a treatment session is initiated at a start point, which start point may be at or about the patient's body temperature at the time the treatment session is initiated (typically a range of about 34 to 38 degrees Centigrade, around a normal body temperature of about 37 degrees Centigrade.
  • the lower point, 34 is due to the coolness of the ear canal in comparison with the rest of the body. It typically will not be above about 37 unless the patient is febrile).
  • the patient's ear canal may be slightly less than body temperature (e.g., about 34 to 36 degrees Centigrade)
  • the starting temperature for the waveform is typically body temperature (the temperature of the inner ear), or about 37 degrees Centigrade.
  • the temperature of the treatment device may not have equilibrated with the ear canal prior to the start of the treatment session, and in such case the start point for at least the first waveform may be at a value closer to room temperature (normally bout 23 to 26 degrees Centigrade).
  • a treatment session may have a total duration of five or ten minutes, up to 20 or 40 minutes or more, depending on factors such as the specific waveform or waveforms delivered, the patient, the condition being treated, the benefit being sought, etc.
  • a treatment session may comprise one or more breaks (i.e., periods wherein no CVS is given).
  • a treatment session may comprise multiple stimulation periods with a break between each stimulation period and may have a total duration of 60 minutes or more.
  • Treatment sessions are preferably once a day, though in some embodiments more frequent treatment sessions ⁇ e.g., two or three times a day or more) may be employed.
  • Day-to-day treatments may be by any suitable schedule: every day, every other day, twice a week, as needed by the patient, etc.
  • the overall pattern of treatment is thus typically chronic (in contrast to "acute,” as used in one-time experimental studies).
  • the present invention provides a vestibular stimulation device for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • the vestibular stimulation device may be configured to deliver any suitable thermal waveform or combination of thermal waveforms, including, but not limited to, those described in U.S. Provisional Patent Application Nos.
  • the vestibular stimulation device is configured to deliver one or more actively controlled, time-varying thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • the vestibular stimulation device is configured to generate a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient and to deliver the prescribed thermal waveform(s) to the vestibular system and/or the nervous system of said patient.
  • the vestibular stimulation device comprises, consists essentially of or consists of an earpiece, a TED and a controller, wherein said TED is thermally coupled to said earpiece and wherein said controller is operatively connected to said TED.
  • the controller may be configured to activate said TED to deliver one or more thermal waveforms to the vestibular system and /or the nervous system of a patient (i.e., to activate the TED such that the earpiece is warmed and/or cooled so as to deliver the thermal waveform(s) to the vestibular system and/or the nervous system of the patient).
  • the controller is configured to generate a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient and to activate the TED to deliver the prescribed thermal waveform(s).
  • the vestibular stimulation device comprises, consists essentially of or consists of an earpiece, a plurality of TEDs and a controller, wherein each of said plurality of TEDs is thermally coupled to said earpiece and wherein said controller is operatively connected to each of said plurality of TEDs.
  • the controller may be configured to selectively and separately activate each of said plurality of TEDs to deliver one or more thermal waveforms to the vestibular system and /or the nervous system of a patient (i.e., to activate one or more of the TEDs such that the earpiece is warmed and/or cooled so as to deliver the thermal waveform(s) to the vestibular system and/or the nervous system of the patient).
  • the controller is configured to generate a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient and to activate the TEDs to deliver the prescribed thermal waveform(s).
  • the vestibular stimulation device comprises, consists essentially of or consists of a pair of earpieces, a pair of TEDs and a controller, wherein one earpiece is configured so as to be insertable into the left ear canal of a patient and the other earpiece is configured so as to be insertable into the right canal of the patient, wherein one TED is thermally coupled to each earpiece and wherein said controller is operatively connected to each TED.
  • the controller may be configured to selectively and separately activate each of said TEDs to deliver one or more thermal waveforms to the vestibular system and /or the nervous system of the patient.
  • the controller is configured to generate a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of the patient and to activate the TEDs to deliver the prescribed thermal waveform(s).
  • the vestibular stimulation device comprises, consists essentially of or consists of a pair of earpieces, a plurality of TEDs and a controller, wherein one earpiece is configured so as to be insertable into the left ear canal of a patient and the other earpiece is configured so as to be insertable into the right canal of the patient, wherein at least one of said plurality of TEDs is thermally coupled to each earpiece and wherein said controller is operatively connected to each TED.
  • the controller may be configured to selectively and separately activate each of said TEDs to deliver one or more thermal waveforms to the vestibular system and /or the nervous system of the patient.
  • the controller is configured to generate a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of the patient and to activate the TEDs to deliver the prescribed thermal waveform(s).
  • the vestibular stimulation device may comprise one or more heat sinks.
  • at least one heat sink is thermally coupled to each earpiece.
  • each TED thermally coupled to an earpiece is thermally coupled between the earpiece and at least one heat sink.
  • the vestibular stimulation device may comprise one or more sensors.
  • the sensor(s) is/are configured to provide feedback data to the controller.
  • the controller is configured (e.g., with computer instructions (i.e., software)) to adjust one or more attributes of TED activation (e.g. , magnitude, duration, wave pattern, etc.) in response to feedback data received from the sensor(s) with which it is associated.
  • the vestibular stimulation device may be configured such that, during delivery of a thermal waveform, the controller activates the TED(s) in a continuous or substantially continuous manner and repeatedly, continuously or substantially continuously adjusts one or more attributes of TED activation in response to feedback data received from one or more sensors (e.g., a temperature sensor configured to provide feedback data associated .with the temperature of the ear canal of a patient).
  • the controller activates the TED(s) in a continuous or substantially continuous manner and repeatedly, continuously or substantially continuously adjusts one or more attributes of TED activation in response to feedback data received from one or more sensors (e.g., a temperature sensor configured to provide feedback data associated .with the temperature of the ear canal of a patient).
  • sensors e.g., a temperature sensor configured to provide feedback data associated .with the temperature of the ear canal of a patient.
  • the vestibular stimulation device may comprise a headband.
  • the headband is configured to position the earpiece(s) in the ear canal(s) of a patient.
  • the vestibular stimulation device 1 comprises a controller
  • a pair of earpieces 12a, 12b a pair of TEDs 13a, 13b and a pair of heat sinks 15a, 15b
  • one TED 13a is thermally connected between one heat sink 15a and an earpiece 12a that is configured so as to be insertable into the left ear canal of a patient
  • the other TED 13b is thermally connected between the a heat sink 15b and an earpiece 12b that is configured so as to be insertable into the right ear canal of a patient
  • the controller 11 is operatively connected to each of the TEDs 13a, 13b by a thermal stimulation conductive line 16a, 16b.
  • each earpiece 12a, 12b is operatively connected to a sensor 14a, 14b (e.g., each earpiece may be thermally connected to a temperature sensor that is configured to detect the temperature of the earpiece), and each of the sensors 14a, 14b is operatively connected to the controller 11 by a wireless connection 17a, 17b (using a radiofrequency transceiver or a Bluetooth connection, for example).
  • a wireless connection 17a, 17b using a radiofrequency transceiver or a Bluetooth connection, for example.
  • Any suitable controller can be used to carry out the present invention, including, but not limited to, those described in U.S. Patent Publication Nos. 2010/0198204 (attorney docket number 9767-31EP2) and 2010/0198282 (attorney docket number 9767-2IP2); in United States Patent Application Nos. 12/970,312 (attorney docket number 9767-3) and 12/970,347 (attorney docket number 9767-32) and in United States Provisional Application Nos. 61/497,761 (attorney docket number 9767-37PR), the disclosure of each of which is incorporated herein by reference in its entirety.
  • the controller may be configured to activate at least one TED.
  • the controller is configured to activate at least one TED to deliver one or more thermal waveforms to the vestibular system and/or the nervous system of a patient (e.g. , by heating and/or cooling the earpiece(s) that is/are thermally coupled to the TED.
  • the controller may be configured to activate the TED(s) based upon a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient (i.e., the controller may be configured to activate the TED(s) so as to deliver the prescribed thermal waveform(s) to the vestibular system and/or the nervous system of the patient).
  • the controller may be configured to selectively and separately activate a plurality of TEDs.
  • the controller may be configured to selectively and separately activate the TED(s) thermally coupled to an earpiece inserted into the left ear canal of a patient and the TED(s) thermally coupled to an earpiece inserted into the right ear canal of a patient (e.g., to deliver a thermal waveform only to the left ear canal of the patient, to deliver a thermal waveform only to right ear canal of the patient or to simultaneously deliver different thermal waveforms to the left and right ear canals of the patient).
  • the controller may be configured to separately activate a plurality of TEDs thermally coupled to a single earpiece.
  • the controller may be configured to activate the TED(s) in any suitable manner, including, but not limited to, activation with direct current and/or electrical pulses.
  • the controller is configured to activate the TED(s) in a continuous or substantially continuous manner, adjusting one or more parameters of TED activation (e.g., magnitude, duration, pulse width, etc.) to deliver the desired thermal stimulus.
  • the controller may be configured such that it continuously or substantially continuously activates each of the TEDs with which it is operatively connected and delivers different thermal stimuli by modulating the type and/or level of activation applied to each TED.
  • the controller may be configured to activate the TED(s) to deliver any suitable thermal waveform or combination of thermal waveforms, including, but not limited to, those described in U.S. Provisional Patent Application Nos. 61/424,132 (attorney docket number 9767-38PR), 61/498,096 (attorney docket number 9797- 38PR2), 61/424,326 (attorney docket number 9767-39PR), 61/498,080 (attorney docket number 9767-39PR2), 61/498,911 (attorney docket number 9767-44PR) and 61/498,943 (attorney docket number 9767-45PR), the disclosure of each of which is incorporated herein by reference in its entirety.
  • the controller is configured to activate the TED(s) to deliver one or more actively controlled, time-varying thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • the controller may also be configured to activate the TED(s) to deliver a constant thermal stimulus to the ear canal(s) of a patient.
  • the controller may be configured to activate the TED(s) so as to maintain the temperature of a patient's ear canal at a target temperature (e.g., to hold a patient's right canal at 20 degrees Centigrade while a thermal waveform is delivered to the patient's left canal).
  • the controller may likewise be configured to deliver one or more placebo waveforms (i.e., to fool a patient into believing one or more thermal waveforms has been delivered even though no such delivery has occurred).
  • the controller is operatively connected to at least one TED via a thermal stimulation conductive line.
  • the controller may be operatively connected to each TED via a separate thermal stimulation conductive line.
  • each of the plurality of separate thermal stimulation conductive lines is bundled together into one or more thermal stimulation leads (e.g., the thermal stimulation conductive lines connected to the TED(s) thermally coupled to the right earpiece may be bundled separately from the thermal stimulation conductive lines connected to the TED(s) thermally coupled to the left earpiece).
  • each thermal stimulation lead is connected to the controller via a lead interface (e.g., one or more thermal stimulation leads may be connected to the controller using an 18-pin connector).
  • the controller is operatively connected to at least one TED via a wireless connection
  • the controller may be configured to receive and/or transmit any suitable data, including, but not limited to, data associated with the parameters, indications and/or approvals of one or more thermal waveforms, data associated with one or more prescriptions, controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, physician feedback data and/or patient information.
  • the controller may be configured to receive and/or transmit data from/to various devices, including, but not limited to, a patient control device, a physician control device, a physician support device, a registry, a TED, a sensor and/or a portable memory device (e.g., an SD memory card).
  • various devices including, but not limited to, a patient control device, a physician control device, a physician support device, a registry, a TED, a sensor and/or a portable memory device (e.g., an SD memory card).
  • the controller is configured to receive data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g., idealized thermal waveforms) from a patient control device, a physician control device, a physician support device, a registry and/or a portable memory device (e.g., an SD memory card); to receive one or more prescriptions from a patient control device, a physician control device, a physician support device, a registry and/or a portable memory device (e.g., an SD memory card); to receive controller feedback data from one or more TEDs and/or one or more sensors; to receive data associated with the delivery of one or more thermal waveforms (e.g., idealized thermal waveforms) from one or more TEDs and/or one or more sensors; to transmit data associated with the delivery of one or more thermal waveforms (e.g., idealized thermal waveforms) to a patient control device, a physician control device, a physician support device, a registry and/or a portable memory device
  • the controller may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the controller comprises memory, a processor and a power supply.
  • the processor may be any commercially available or custom microprocessor.
  • Memory can include, but is not limited to, the following types of devices: cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.
  • the power supply may be an internal power supply (e.g., one or more rechargeable batteries that may be recharged without first being removed from the controller).
  • the controller's memory may comprise any suitable software and/or data, including, but not limited to, an operating system, applications, data and input/output (I/O) drivers.
  • the controller may use any suitable operating system, including, but not limited to, OS/2, ATX, OS/390 or System390 from International Business Machines Corp. (Armonk, NY), Window CE, Windows NT, Windows95, Windows98, Windows2000, Windows 7 or Windows Vista from Microsoft Corp. (Redmond, WA), Mac OS from Apple, Inc. (Cupertino, CA), Unix, Linux or Android.
  • the controller may comprise any suitable application, including, but not limited to, one or more programs configured to implement one or more of the various features of the present invention.
  • the controller may comprise a waveform module that enables a user to generate and/or modify the parameters, indications and/or approvals of one or more thermal waveforms; a treatment module that enables a user to generate, modify, update and/or extend a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient; a control module configured to activate one or more TEDs; a network module configured to receive and/or transmit data; a GUI module configured to display information and/or accept user input; a feedback module configured to receive, transmit, and/or analyze controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, physician feedback data and/or patient information; an alert generation module configured to generate one or more alert messages
  • two or more of the aforementioned modules are combined to form a single module configured to carry out the function(s) of each of the individual modules (e.g., the controller may comprise a waveform-treatment module that enables a user to generate and/or modify one or more thermal waveforms and to generate, modify, update and/or extend a prescription).
  • the controller may comprise a waveform generation module that enables a user to generate the parameters, indications and/or approvals of one or more thermal waveforms and a waveform update module that enables a user to modify the parameters, indications and/or approvals of one or more thermal waveforms).
  • the control module rather than the feedback module, may be configured to receive/analyze controller feedback data).
  • the controller comprises a waveform module whereby a user may generate and/or modify the parameters, indications and/or approvals of one or more thermal waveforms.
  • the waveform module comprises software that enables a user to generate and/or modify the parameters of one or more thermal waveforms by point-to-point design and/or by utilizing mathematical functions.
  • the waveform module may comprise software that enables a user to generate and/or modify the parameters, indications and/or approvals of a thermal waveform by selecting/altering one or more parameters, including, but not limited to, shape, frequency, amplitude and duration.
  • the waveform module enables a user to retrieve/select a thermal waveform from a database and then modify the parameters of that thermal waveform to generate a new thermal waveform.
  • the waveform module comprises software that enables a user to generate and/or modify the parameters, indications and/or approvals of one or more thermal waveforms using an interactive touch screen.
  • the waveform module may comprise software that enables a user to generate the parameters of a thermal waveform by drawing the desired waveform on an interactive touch screen ( Figure 3).
  • the waveform module may enable a user to modify the parameters of a thermal waveform by highlighting one or more points on the waveform and moving the point(s) to a new location (e.g., a higher/lower temperature) (Figure 4).
  • the waveform module comprises software that automatically adjusts the parameters of the thermal waveform(s) created by a user to account for system limitations.
  • the waveform module may comprise software that automatically adjusts the slope of a thermal waveform in accordance with the minimum maximum temperature and/or the rate of temperature change that is achievable using a particular combination of earpiece(s), TED(s), etc. That is, the waveform module may comprise software that prevents a user from generating parameters for a thermal waveform that cannot be delivered because of system limitations.
  • the waveform module comprises software that enables a user to protect one or more thermal waveforms (i.e. , to prevent one or more users from modifying the parameters, indications and/or approvals of the thermal waveform(s) and/or from deleting the thermal waveform(s) from a waveform database).
  • the waveform module may comprise software that enables a user to protect one or more idealized thermal waveforms (e.g., by requiring users to enter a specified password prior to modifying and/or deleting the idealized thermal waveform(s)).
  • the waveform module comprises software that enables a user to remove the protected status from one or more thermal waveforms.
  • the waveform module may comprise software that enables a user to remove the protected status from one or more idealized thermal waveforms (e.g. , by entering the appropriate password).
  • the waveform module is configured to automatically generate and/or modify the parameters, indications and/or approvals of one or more thermal waveforms (e.g. , idealized thermal waveforms) in response to data received from one or more devices/modules.
  • the waveform module may be configured to automatically update one or more thermal waveforms responsive to data received from one or more TEDs and/or one or more sensors.
  • the waveform module may be configured to retrieve the parameters, indications and/or approvals of one or more thermal waveforms from any suitable database, including, but not limited to, a waveform database residing in the controller, a waveform database residing in a patient control device, a waveform database residing in a physician control device, a waveform database residing in a physician support device, a waveform database residing in a registry and/or a waveform database residing in a portable memory device (e.g., an SD memory card).
  • a portable memory device e.g., an SD memory card
  • Waveform parameters, indications and/or approvals generated and/or modified by the waveform module may be stored in a database.
  • the generated/modified parameters, indications and/or approvals are stored in a waveform database comprising data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g., idealized thermal waveforms).
  • the generated/modified waveform parameters, indications and/or approvals may be stored in a waveform database residing in the controller, a waveform database residing in a patient control device, a waveform database residing in a physician control device, a waveform database residing in a physician support device, a waveform database residing in a registry and/or a waveform database residing in a portable memory device (e.g., an SD memory card).
  • a waveform database residing in the controller a waveform database residing in a patient control device
  • a waveform database residing in a physician control device a waveform database residing in a physician support device
  • a waveform database residing in a registry e.g., an SD memory card
  • the controller comprises a treatment module whereby a user (e.g., a physician) may generate, modify, update and/or extend a prescription.
  • a user e.g., a physician
  • the treatment module may enable a user to generate, modify, update and/or extend a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • the treatment module comprises software that enables a user to select one or more thermal waveforms from a database (e.g., an idealized thermal waveform from an idealized waveform database) and to provide instructions as to when/how each of those waveforms should be administered.
  • a database e.g., an idealized thermal waveform from an idealized waveform database
  • a treatment module may comprise software that enables a user to provide instructions as to how long a treatment schedule is to last (Figure 5), to provide instructions as to how many treatments may be administered each day (Figure 5), to provide instructions as to how often each thermal waveform is to be administered (Figure 6), to provide instructions as to what time(s) of day each thermal waveform is to be administered ( Figure 6 and 9), to select one or more idealized thermal waveforms from a database ( Figure 7), to provide instructions regarding whether each of the selected thermal waveforms is to be delivered to the right and/or left ear canal of a patient ( Figure 8), etc.
  • the treatment module comprises software that enables a user to modify, update and/or extend a prescription by changing one or more parameters of the prescription ( Figure 10), including, but not limited to, which thermal waveform(s) are delivered, frequency with which the thermal waveform(s) is/are delivered, and the expiration date of the prescription.
  • Any suitable prescription may be modified, updated and/or extended, including, but not limited to, prescriptions stored in a prescription database (e.g., a prescription database residing in the controller, in a patient control device, in a physician control device, in a physician support device, in a registry or in a portable memory device, such as a portable SD memory card).
  • the treatment module may be configured to retrieve/select thermal waveforms from any suitable database, including, but not limited to, a waveform database residing in the controller, a waveform database residing in a patient control device, a waveform database residing in a physician control device, a waveform database residing in a physician support device, a waveform database residing in a registry and/or a waveform database residing in a portable memory device (e.g., an SD memory card).
  • a portable memory device e.g., an SD memory card
  • the treatment module may be configured to retrieve prescriptions from any suitable database, including, but not limited to, a prescription database residing in the controller, a prescription database residing in a patient control device, a prescription database residing in a physician control device, a prescription database residing in a physician support device, a prescription database residing in a registry and/or a prescription database residing in a portable memory device (e.g., an SD memory card).
  • a prescription database residing in the controller a prescription database residing in a patient control device
  • a prescription database residing in a physician control device a prescription database residing in a physician support device
  • a prescription database residing in a registry e.g., an SD memory card
  • Prescriptions generated, modified, updated and/or extended by the treatment module may be added to a database comprising one or more prescriptions.
  • the prescriptions may be stored in a prescription database residing in the controller, a prescription database residing in a patient control device, a prescription database residing in a physician control device, a prescription database residing in a physician support device, a prescription database residing in a registry and/or a prescription database residing in a portable memory device.
  • the controller comprises a control module configured to activate at least one TED (i.e., to control the magnitude, duration, waveform and other attributes of stimulation delivered by the at least one TED).
  • the control module may be configured to activate the TED(s) to deliver any suitable thermal waveform or combination of thermal waveforms, including, but not limited to, those described in U.S. Provisional Patent Application Nos.
  • 61/424,132 attorney docket number 9767-38PR
  • 61/498,096 attorney docket number 9797- 38PR2
  • 61/424,326 attorney docket number 9767-39PR
  • 61/498,080 attorney docket number 9767-39PR2
  • 61/498,911 attorney docket number 9767-44PR
  • 61/498,943 attorney docket number 9767-45PR
  • control module is configured to selectively and separately activate a plurality of
  • TEDs e.g., by activating only one of said plurality of TEDs, by heating one TED and cooling another, by sequentially activating the TEDs, by activating different TEDs using different temperature/timing parameters, combinations of some or all of the foregoing, etc.).
  • control module is configured to activate the TED(s) based upon a prescription.
  • control module may be configured to activate one or more TEDs based upon a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • control module is configured to receive and/or retrieve instructions for delivering a thermal waveform from a database.
  • the control may be configured to receive and/or retrieve a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient from a prescription database residing in the controller, from a prescription database residing in a patient control device, from a prescription database residing in a physician control device, from a prescription database residing in a physician support device, from a prescription database residing in a registry and/or from a prescription database residing in a portable memory device (e.g., an SD memory card).
  • a portable memory device e.g., an SD memory card
  • the control module is configured to adjust one or more attributes of TED activation (e.g., magnitude, duration, wave pattern, etc.) in response to controller feedback data received from one or more TEDs and/or one or more sensors.
  • the control module may be configured to increase/decrease the magnitude of TED activation in response to controller feedback data indicating that an earpiece that is thermally coupled to the TED has not yet reached a target temperature (e.g., the control module may be configured to increase the current flowing through the TED in response to controller feedback data indicating that the temperature of the earpiece has not yet dropped to the target temperature in response to a cooling waveform).
  • the controller comprises a network module configured to receive, retrieve and/or transmit data.
  • the network module may be configured to receive, retrieve and/or transmit data from/to any suitable device/module/database, including, but not limited to, other modules residing in the controller, databases residing in the controller, a patient control device, a physician control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • any suitable device/module/database including, but not limited to, other modules residing in the controller, databases residing in the controller, a patient control device, a physician control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • the network module may be configured to receive, retrieve and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the network module may be configured to receive, retrieve and/or transmit any suitable data, including, but not limited to, data associated with the parameters, indications and/or approvals of one or more thermal waveforms, one or more prescriptions, controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and/or patient information.
  • data associated with the parameters, indications and/or approvals of one or more thermal waveforms, one or more prescriptions controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and/or patient information.
  • the network module is configured to receive and/or retrieve data associated with the parameters, indications and/or approvals of one or more thermal waveforms from a waveform module/database residing in the controller, from a patient control device, from a physician control device, from a physician support device, from a registry and/or from a portable memory device.
  • the network module is configured to receive and/or retrieve one or more prescriptions from a treatment module residing in the controller, from a prescription database residing in the controller, from a patient control device, from a physician control device, from a physician support device, from a registry and/or from a portable memory device.
  • the network module is configured to receive and/or retrieve controller feedback data, data associated with the delivery of one or more thermal waveforms and/or data associated with the fit of one or more earpieces from a control module residing in the controller, from an impedance module residing in the controller, from a feedback module/database residing in the controller, from one or more TEDs and/or from one or more sensors.
  • the network module is configured to receive and/or retrieve patient feedback data, physician feedback data and/or patient information from a feedback module/database residing in the controller, from a GUI module residing in the controller, from a patient information database residing in the controller, from a patient control device, from a physician control device, from a physician support device, from a registry and/or from a portable memory device.
  • the network module is configured to transmit data associated with the parameters, indications and/or approvals of one or more thermal waveforms to a waveform module/database residing in the controller, to a treatment module residing in the controller, to a patient control device, to a physician control device, to a physician support device, to a registry and/or a to portable memory device.
  • the network module is configured to transmit one or more prescriptions to a treatment module residing in the controller, to a prescription database residing in the controller, to a patient control device, to a physician control device, to a physician support device, to a registry and/or to a portable memory device.
  • the network module is configured to transmit controller feedback data, data associated with the delivery of one or more thermal waveforms and/or data associated with the fit of one or more earpieces to a control module residing in the controller, to a feedback module/database residing in the controller, to a patient control device, to a physician control device, to a physician support device, to a registry and/or to a portable memory device.
  • the network module is configured to transmit patient feedback data, physician feedback data and/or patient information to a feedback module/database residing in the controller, to a patient information database residing in the controller, to a patient control device, to a physician control device, to a physician support device, to a registry and/or to a portable memory device.
  • the network module is configured to access a database comprising data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g., idealized thermal waveforms).
  • the network module maybe configured to access a waveform database residing in the controller, a waveform database residing in a patient control device, a waveform database residing in a physician control device, a waveform database residing in a physician support device, a waveform database residing in a registry and/or a waveform database residing in a portable memory device.
  • the network module is configured to access a database comprising one or more prescriptions.
  • the network module maybe configured to access a prescription database residing in the controller, a prescription database residing in a patient control device, a prescription database residing in a physician control device, a prescription database residing in a physician support device, a prescription database residing in a registry and/or a prescription database residing in a portable memory device.
  • the network module is configured to access a database comprising controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data and/or physician feedback data.
  • the network module maybe configured to access a feedback database residing in the controller, a feedback database residing in a patient control device, a feedback database residing in a physician control device, a feedback database residing in a physician support device, a feedback database residing in a registry and/or a feedback database residing in a portable memory device.
  • the network module is configured to access a database comprising patient information.
  • the network module maybe configured to access a patient information database residing in the controller, a patient information database residing in a patient control device, a patient information database residing in a physician control device, a patient information database residing in a physician support device, a patient information database residing in a registry and/or a patient information database residing in a portable memory device.
  • the controller comprises a GUI module configured to display information and/or to accept user input.
  • GUI Any suitable GUI may be used, including, but not limited to, a keyboard, a mouse, an LCD display with one or more associated entry keys and an interactive touch screen.
  • the GUI may comprise a static pressure touch-sensitive display, a capacitive touch-sensitive display, a resistive touch-sensitive display, an electrostatic capacity proximity sensor, a magnetic proximity sensor and /or an infrared proximity sensor. See, e.g., U.S. Patent Publication Nos. 2011/0271222, 2011/0273575, 2011/0275414 and 2011/0275416.
  • the GUI module may be configured to display any suitable information, including, but not limited to, data associated with the delivery of one or more thermal waveforms.
  • the GUI module may be configured to display the current date and/or time (Figure 10); the current temperature(s) of the earpiece(s) associated with the controller; the current temperature(s) of a patient's ear canal(s); the current temperature(s) of a patient's inner ear(s); the current temperature(s) of the heat sink(s) associated with the controller; one or more target temperatures (Figure 11); the amount of time that has elapsed since the onset of delivery of one or more thermal waveforms (Figure 11); the amount of time remaining in the delivery of one or more thermal waveforms ( Figure 11); the amount of time that has elapsed since the onset of a treatment session; the amount of time remaining in a treatment session; a graphical representation of the thermal waveform being applied ( Figure 11); the number of treatment sessions that have been administered for a prescription; the number of treatment sessions remaining in a
  • a patient made about his/her treatment session(s) e.g., comments made to a physician, submitted in response to an automated survey and/or recorded in a treatment diary
  • the impedance between an earpiece inserted into the ear canal of a patient and an electrode affixed to a second location on/in said patient's body e.g., an electrode placed in or adjacent to the patient's other ear canal
  • the rate at which a patient's inner ear cools in response to a cooling stimulus e.g., data from a temperature sensor, such as thermistor, that monitors how quickly the inner ear cools in response to a cooling waveform
  • the rate at which a patient's inner ear warms in response to a warming stimulus e.g., data from a temperature sensor, such as
  • the GUI module may be configured to accept any suitable user input, including, but not limited to, instructions for generating and/or modifying the parameters, indications and/or approvals of a thermal waveforms; instructions for generating, modifying, updating and/or extending a prescription; patient feedback, physician feedback and/or patient information.
  • the GUI module may be configured to accept a pain score and/or patient comments regarding the effectiveness of a treatment session.
  • the GUI module is configured to allow a user to initiate/stop a treatment session (e.g. , by pushing/selecting an emergency shutoff button icon) ( Figure 11).
  • the controller comprises a feedback module configured to receive, transmit and/or analyze data.
  • the feedback module may be configured to receive and/or transmit data from/to any suitable device/module/database, including, but not limited to, other modules residing in the controller, databases residing in the controller, a patient control device, a physician control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • any suitable device/module/database including, but not limited to, other modules residing in the controller, databases residing in the controller, a patient control device, a physician control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • the feedback module may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the feedback module may be configured to receive, transmit and/or analyze any suitable data, including, but not limited to, controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and/or patient information.
  • the feedback module is configured to receive and/or analyze controller feedback data, data associated with the delivery of one or more thermal waveforms and/or data associated with the fit of one or more earpieces from an impedance module residing in the controller, from a feedback database residing in the controller, from one or more TEDs and/or from one or more sensors.
  • the feedback module may be configured to analyze the accuracy with which one or more prescribed waveforms was delivered to a patient, the fit of an earpiece based upon the rate at which the temperature of the earpiece changes in response to a cooling/warming waveform, the slew rate associated with one or more TEDs, the impedance between an earpiece positioned in the left ear canal of a patient and an earpiece positioned in the right ear canal of a patient, the impedance between an earpiece positioned in the ear canal of a patient and an electrode affixed to a second location on/in the patient's body, etc.
  • the feedback module is configured to receive and/or analyze patient feedback data, physician feedback data and/or patient information from a GUI module residing in the controller, from a feedback database residing in the controller, from a patient information database residing in the controller, from a patient control device, from a physician control device, from a physician support device, from a registry and/or from a portable memory device.
  • the feedback module may be configured to analyze the effectiveness of a given thermal waveform or combination of thermal waveforms (e.g.
  • the effect(s) of one or more waveform modifications e.g., by analyzing whether/how much a given waveform modification changed the effectiveness of a thermal waveform in treating a disease/disorder, etc.
  • the feedback module is configured to transmit controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data, patient information and/or data associated with its analysis to a control module residing in the controller, to a feedback database residing in the controller, to a patient information database residing in the controller, to a patient control device, to a physician control device, to a physician support device, to a registry and/or to a portable memory device (e.g., an SD memory card).
  • a portable memory device e.g., an SD memory card
  • the controller comprises an alert generation module configured to generate one or more alert messages.
  • the alert generation module may be configured to generate any suitable alert message, including, but not limited to, a reminder that a patient is due for a treatment session; a reminder that a patient must enter patient feedback data (e.g., a pain score) following a treatment session; an indication of the number of treatment sessions remaining in a prescription; an error message indicating that a treatment session has been interrupted due to a system error; an alert indicating that one or more idealized thermal waveforms has been modified; an alert indicating that a given modification is likely to increase/decrease the effectiveness of a given thermal waveform and/or an alert indicating that a given thermal waveform, class of thermal waveforms or combination of thermal waveforms has been identified as being indicated and/or approved for use in the treatment of a disease/disorder; a reminder that a patient must contact his/her physician to update/extend his/her prescription and a warning that the controller's internal power supply is low.
  • patient feedback data e.g., a pain score
  • the alert generation module is configured to communicate with various devices/modules, including, but not limited to, a patient control device, a physician control device, a physician support device, a TED, a sensor, a portable memory device (e.g., an SD memory card) and other modules of the controller.
  • the alert generation module may be configured to provide instructions to the GUI module and/or the tone generation module for displaying one or more alert messages and/or for generation an audible tone to alert a user of the presence of the one or more alert messages.
  • the graphical user interface module may be configured to display the one or more alert messages immediately upon generation or upon interaction with a user (e.g., an alert notification icon may be generated, with the alert message being displayed only after the user indicates that he/she wishes to view the message).
  • the controller comprises a tone generation module configured to produce audible tones.
  • the tone generation module comprises a piezo buzzer.
  • Audible tones may be produced to alert a user to various circumstances/events, including, but not limited to, the start of a treatment session, the end of a treatment session, interruption of a treatment session, low battery power and the existence of an unread/unviewed alert message.
  • Audible tones may be generated repeatedly in response to a single circumstance/event (e.g., an audible tone may be generated repeatedly until the user views/reads the message) and may become progressively louder and/or more frequent with time.
  • the controller comprises a visual indicator module configured to notify a user of the existence of an unread/unviewed alert message and/or to notify the user that a treatment session is in progress.
  • the visual indicator module comprises an LED indicator light.
  • the visual indicator module may be activated repeatedly in response to a single alert message (e.g., an LED light may be illuminated repeatedly until the user views/reads the message) or may remain activated until the user views/reads the message.
  • an LED indicator light may be illuminated throughout a treatment session and deactivated upon completion of the treatment session., and may change color to signal various events within a treatment session (e.g., the light may appear blue during cooling periods and appear red during heating periods).
  • the controller comprises an impedance module configured to detect and/or monitor the impedance and/or capacitance between an earpiece inserted into the ear canal of a patient and an electrode affixed to a second location on/in said patient's body.
  • the impedance module may be configured to deliver an electrical current to the earpiece and to measure and/or record the impedance and/or capacitance between the earpiece and the electrode.
  • the impedance module may be configured to detect and/or monitor the impedance and/or capacitance between an earpiece inserted into the right ear canal of a patient and an earpiece inserted into the left ear canal of said patient.
  • the impedance module may be configured to deliver an electrical current to the earpiece inserted into the right ear canal of the patient and to measure and/or record the impedance and/or capacitance between the two earpieces.
  • each of the earpieces is in substantially good thermal contact with the patient's ear canal, then the earpieces will also be in substantially good electrical contact with the patient's ear canals, and the patient's head will substantially complete an electrical circuit between the earpieces.
  • the impedance module if either of the earpieces is not in substantially good thermal contact with the patient's ear canal, then there will generally be poor electrical contact with the patient's ear canal, and the patient's head will not complete the electrical circuit between the earpieces and an open circuit will be detected by the impedance module.
  • the impedance value between an earpiece inserted into the ear canal of the patient and the electrode affixed to a second location may be used to estimate the thermal contact between the earpiece(s) and the patient's ear canal(s).
  • impedance values may be detected for a range of patients to determine a range of impedance values in which it may be assumed that the earpiece(s) is/are in substantially good thermal contact with the patient's ear canal(s).
  • the impedance value may be detected, and if the impedance value is within the acceptable range, it may be assumed that there is substantially good thermal contact between the earpiece(s) and the patient's ear canal(s).
  • the impedance value between the earpiece inserted into the right ear canal of the patient and the earpiece inserted into the left canal of the patient may be detected and used as a patient-specific baseline to later determine whether the patient is using the vestibular stimulation device in the proper configuration (i.e., whether the earpieces are properly fitted into the patient's ear canals during a given treatment session).
  • the impedance module may be configured to monitor the impedance value between an earpiece inserted into the ear canal of a patient and an electrode affixed to a second location on/in said patient's body (e.g., between two earpieces), and the impedance values may be analyzed (e.g. , by a medical health professional or the impedance module) to determine whether the earpiece(s) is/was properly fitted at various times before, during and/or after delivery of the thermal waveform(s).
  • the impedance module may be configured to provide feedback to the user if/when the impedance value indicates that the earpiece(s) are not in substantially good thermal contact with the patient's ear canal(s). In this configuration, the impedance module may provide an estimation of a degree of thermal contact between the earpiece(s) and the patient's ear canal(s) in real-time or in data recorded and analyzed at a later time.
  • the impedance module may be configured to provide controller feedback data to the control module so that the control module may modulate the amplitude of the waveform(s) delivered by the TED(s) responsive to the degree of thermal contact between the earpiece(s) and the patient's ear canal(s). For example, if the impedance module determines that there is a poor fit and poor thermal contact between the earpiece(s) and the ear canal(s), then the control module may increase the thermal output of the TED(s) to compensate for the poor thermal contact.
  • the controller comprises a security module configured to prevent unauthorized use of the controller (i.e., to prevent unauthorized persons from using the vestibular stimulation device, to prevent authorized persons from using the vestibular stimulation device in an unauthorized manner, etc.).
  • the security module may be configured to prevent unauthorized use of the controller using any suitable means of security, including, but not limited to, password protection and data encryption.
  • the security module may be configured such that a user is required to input a designated password prior to initializing treatment; generating and/or modifying a thermal waveform;, generating, modifying, updating and/or extending a prescription; entering/viewing patient feedback data; entering/viewing physician feedback data and/or entering/viewing patient information ( Figure 12).
  • prescriptions are provided in an encrypted format, and the security module is configured such that the prescriptions can only be decrypted by the vestibular stimulation device assigned to or belonging to the patient for whom the prescription was generated.
  • prescriptions are provided in an encrypted format, and the security module is configured such that the prescriptions can only be decrypted by inputting a designated decryption key.
  • a patient may be required to purchase a decryption key and/or password for each treatment session, prescription, refill, etc.
  • the controller comprises a safety module configured to deactivate the controller in the event of a system malfunction and/or failure.
  • the safety module may be configured to deactivate the controller for any suitable reason, including, but not limited to, excessive heating and/or cooling of an earpiece, excessive heating and/or cooling of a heat sink, a loss of thermal coupling between an earpiece and the TED(s) with which it is associated, a loss of thermal coupling between a heat sink and the TED(s) with which it is associated, patient noncompliance (e.g., if the patient has removed the earpiece(s) during a treatment session) and faulty signaling from the controller to the associated TED(s).
  • patient noncompliance e.g., if the patient has removed the earpiece(s) during a treatment session
  • the safety module is configured to deactivate the controller if/when the temperature of an earpiece surpasses a specified safety threshold.
  • the safety module may be configured to deactivate the controller if/when the temperature of the earpiece drops below about 10 degrees Centigrade and/or rises above about 50 degrees Centigrade.
  • the safety module is configured to deactivate the controller if/when the temperature of a heat sink that is thermally coupled to an earpiece surpasses a specified safety threshold.
  • the safety module may be configured to deactivate the controller if/when the temperature of the heat sink-drops below about 5 degrees Centigrade and/or rises above about 50 degrees Centigrade.
  • the safety module is configured to deactivate the controller if/when one or more of the activation signals sent from the controller to the associated TED(s) indicates that the system is may be operating outside of a predefined safety range.
  • the safety module may be configured to deactivate the controller if/when an activation signal sent from the controller to an associated TED exceeds the level of activation that would normally be required to deliver the prescribed thermal waveform in a properly functioning system.
  • the controller may comprise any suitable data, including, but not limited to, static and/or dynamic data used by the operating system, applications, I/O device drivers and other software components, controller feedback data, data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g., idealized thermal waveforms), data associated with one or more prescriptions, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and patient information.
  • thermal waveforms e.g., idealized thermal waveforms
  • the controller may comprise a waveform database comprising data associated with the parameters, indications and/or approvals of one or more idealized thermal waveforms; a prescription database comprising data associated with one or more prescriptions; a feedback database comprising controller feedback data, data associated with the delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of a patient, patient feedback data and physician feedback data and/or a patient history database comprising data associated with one or more patients.
  • two or more of the aforementioned databases are combined to form a single database comprising data from each of the individual databases (e.g., the controller may comprise a feedback- history database comprising data associated with the delivery of one or more thermal waveforms and patient information).
  • one of the aforementioned databases is split into two or more distinct databases (e.g., the controller may comprise a controller feedback database comprising controller feedback data, a delivery feedback database comprising data associated with the specific parameters of the thermal waveform(s) delivered to a patient, a patient feedback database comprising patient feedback data and a physician feedback database comprising physician feedback data).
  • the controller may comprise a controller feedback database comprising controller feedback data, a delivery feedback database comprising data associated with the specific parameters of the thermal waveform(s) delivered to a patient, a patient feedback database comprising patient feedback data and a physician feedback database comprising physician feedback data).
  • one or more of the data types described below with respect to one of the databases described below is stored in one of the other databases described below (e.g., the patient information database, rather than the feedback database, may be configured to receive/store patient feedback data).
  • data is transmitted, received and/or stored in a controlled format (e.g.
  • the controller may be configured to transmit, receive and store data in a manner that ensures compliance with any and all applicable laws and/or regulations (e.g., the Health Insurance Portability and Accountability Act of 1996 (P.L. 104- 191 ; "HIP AA”)).
  • laws and/or regulations e.g., the Health Insurance Portability and Accountability Act of 1996 (P.L. 104- 191 ; "HIP AA"
  • the controller comprises a waveform database configured to receive, store and/or transmit data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g, one or more idealized thermal waveforms).
  • the waveform database is configured such that one or more of the thermal waveforms stored therein is/are protected (e.g., users may be prevented from modifying and/or deleting the idealized thermal waveform(s) stored in the waveform database).
  • the waveform database may comprise any suitable type of memory including, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.
  • the waveform database comprises a portable memory device, such as an SD memory card or a USB memory stick.
  • the waveform database may comprise an SD memory card interface and one or more prescriptions may be stored on a portable SD memory card.
  • the waveform database may be configured to receive and/or transmit data from/to any suitable device/module/database, including, but not limited to, modules residing in the controller, a patient control device, a physician control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g. , an SD memory card).
  • modules residing in the controller including, but not limited to, modules residing in the controller, a patient control device, a physician control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g. , an SD memory card).
  • the waveform database may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the controller comprises a prescription database configured to receive, transmit and/or store one or more prescriptions, wherein each prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • the prescription database may comprise any suitable type of memory including, but not limited to, cache,
  • the prescription database comprises a portable memory device, such as an SD memory card or a USB memory stick.
  • the prescription database may comprise an SD memory card interface and one or more prescriptions may be stored on a portable SD memory card.
  • the prescription database may be configured to receive and/or transmit data from/to any suitable device/module/database, including, but not limited to, modules residing in the controller, a patient control device, a physician control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • modules residing in the controller including, but not limited to, modules residing in the controller, a patient control device, a physician control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • the prescription database may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the controller comprises a feedback database configured to receive, transmit and/or store feedback data.
  • the feedback database may comprise any suitable type of memory including, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.
  • the feedback database comprises a portable memory device, such as an SD memory card or a USB memory stick.
  • the feedback database may comprise an SD memory card interface and one or more prescriptions may be stored on a portable SD memory card.
  • the feedback database may be configured to receive and/or transmit feedback data from/to any suitable device/module/database, including, but not limited to, modules residing in the controller, a patient control device, a physician control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • modules residing in the controller including, but not limited to, modules residing in the controller, a patient control device, a physician control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • the feedback database may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • Feedback data may comprise any suitable data, including, but not limited to, controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and/or patient information.
  • the feedback database may comprise a log file detailing the target time/temperature parameters of one or more prescribed thermal waveform(s); the time/temperature parameters of the thermal waveform(s) delivered to a patient; the date/time of delivery of the thermal waveform(s) delivered to a patient; the temperature(s) of a patient's ear canal(s) at various time points before, during and/or after delivery of one or more thermal waveforms; the temperature(s) of a patient's inner ear(s) at various time points before, during and/or after delivery of one or more thermal waveforms; the fit of one or more earpieces at various time points before, during and/or after delivery of one or more thermal waveforms; an estimate of the thermal contact between one or more earpieces and a
  • a patient made about his/her treatment session(s) e.g., comments made to a physician, submitted in response to an automated survey and/or recorded in a treatment diary
  • the impedance between an earpiece inserted into the ear canal of a patient and an electrode affixed to a second location on/in said patient's body e.g., an electrode placed in or adjacent to the patient's other ear canal
  • the rate at which an earpiece is cooled in response to a cooling stimulus e.g., data from a temperature sensor, such as thermistor, that monitors how quickly the earpiece cools in response to a cooling waveform
  • the rate at which an earpiece is warmed in response to a warming stimulus e.g., data from a temperature sensor, such as a thermist
  • data from a temperature sensor such as thermistor, that monitors how quickly the ear canal and/or the inner ear cools in response to a cooling waveform
  • the rate at which a patient's ear canal and/or inner ear warmed in response to a warming stimulus e.g., data from a temperature sensor, such as a thermistor, that monitors how quickly the ear canal and/or the inner ear warms in response to a warming waveform
  • patient comments regarding the subjective fit of one or more earpieces physician comments regarding the effectiveness of one or more thermal waveforms and/or physician comments regarding the effect(s) of one or more waveform modifications.
  • the controller comprises a patient history database configured to receive, transmit and/or store patient information.
  • the patient history database may comprise any suitable type of memory including, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.
  • the patient history database comprises a portable memory device, such as an SD memory card or a USB memory stick.
  • the patient history database may comprise an SD memory card interface and one or more prescriptions may be stored on a portable SD memory card.
  • the patient history database may be configured to receive and/or transmit data from/to any suitable device/module/database, including, but not limited to, modules residing in the controller, a patient control device, a physician control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • modules residing in the controller including, but not limited to, modules residing in the controller, a patient control device, a physician control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • the patient history database may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • Patient information may comprise any suitable information that is associated with a patient, including, but not limited to, the patient's medical history, the patient's current symptoms (if any),the patient's present diagnosis (if any), the patient's current prescriptions (if any) and data associated with the delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of the patient.
  • the controller may comprise any I/O device drivers, including, but not limited to, software routines accessed through the operating system by the applications to communicate with devices such as I/O ports, memory components, TEDs and/or sensors.
  • the controller may be configured (e.g., with computer instructions (i.e., software)) to operate in a plurality of distinct modes.
  • the controller may be configured to permit access to some modules, databases and/or functionalities and to prevent access to other modules, database and/or functionalities.
  • the controller may be configured to operate in a patient mode, wherein the user is allowed to perform patient-oriented tasks, such as starting/stopping a treatment session and/or providing feedback regarding the effectiveness of a treatment session, but is prevented from accessing other modules/databases/functionalities (e.g., the user may be prevented generating, modifying, updating and/or extending prescriptions).
  • the controller may be configured to operate in a physician mode, wherein the user is allowed to perform physician-oriented tasks, such as generating, modifying, updating and/or extending a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient, but is prevented from accessing other modules/databases/functionalities (e.g., the user may be prevented from generating and/or modifying one or more thermal waveforms).
  • physician-oriented tasks such as generating, modifying, updating and/or extending a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient, but is prevented from accessing other modules/databases/functionalities (e.g., the user may be prevented from generating and/or modifying one or more thermal waveforms).
  • the controller may be configured to operate in a researcher mode, wherein the user is allowed to perform researcher- oriented tasks, such as generating and/or modifying one or more idealized thermal waveforms, but is prevented from accessing other modules/databases/functionalities (e.g., the user may be prevented from modifying the underlying operational parameters of the controller).
  • the controller may be configured to operate in an engineer mode, wherein the user is allowed to access all of the controller's modules/databases/functionalities.
  • Each mode may be protected via a unique security measure (e.g., the controller may be configured such that each mode is protected by a unique password).
  • the controller 11 comprises memory 110, a processor 111 and a power supply 112 (e.g., an internal power supply), wherein memory 110 is representative of the overall hierarchy of memory devices containing software and data used to implement the functionality of the controller 11 and wherein the processor 111 communicates with the memory 110 via an address/data bus 1100.
  • a power supply 112 e.g., an internal power supply
  • memory 110 comprises an operating system 110a, applications 110b (e.g., a waveform module 11a configured to generate and/or modify the parameters, indications and/or approvals of one or more thermal waveforms; a treatment module lib configured to generate, modify, update and/or extend a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient; a control module 11c configured to activate at least one TED to deliver one or more thermal waveforms to the vestibular system and/or the nervous system of a patient; a network module lid configured to receive and/or transmit data, a GUI module lie configured to display information and/or accept user input and/or a feedback module llf configured to receive, transmit, and/or analyze data), data 110c (e.g., a waveform database llh comprising data associated with the parameters, indications and/or approvals of one or more thermal waveforms; a prescription database Hi comprising at least one prescription comprising
  • data 110c comprises one or more databases stored on a portable memory device.
  • data 110c may comprise an SD memory card interface and a portable SD memory card comprising a waveform database llh, a prescription database Hi, a feedback database llj and/or a patient history database Ilk.
  • control module 11c is configured to activate one or more TEDs to delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • the control module 11c may be configured to activate the TED(s) based upon a prescription stored in the prescription database Hi.
  • the prescription is stored on an SD memory card inserted into an SD memory card interface.
  • the network module lid is configured to receive data associated with the parameters, indications and/or approvals of one or more thermal waveforms from the waveform module 11a, a patient control device, a physician control device, a physician support device, a registry and/or a portable memory device (e.g., an SD memory card) and to transmit the data to the waveform database llh for storage.
  • the data is stored on an SD memory card inserted into an SD memory card interface.
  • the network module lid is configured to retrieve data associated with the parameters, indications and/or approvals of one or more thermal waveforms from the waveform database llh, a patient control device, a physician control device, a physician support device, a registry and/or a portable memory device (e.g., an SD memory card) and to transmit the data to the waveform module 11a and/or the treatment module lib.
  • a portable memory device e.g., an SD memory card
  • the network module lid is configured to receive one or more prescriptions from the treatment module lib, a patient control device, a physician control device, a physician support device, a registry and/or a portable memory device (e.g., an SD memory card) and to transmit the prescription(s) to the prescription database Hi for storage.
  • the prescription(s) is/are stored on an SD memory card inserted into an SD memory card interface.
  • the network module lid is configured to retrieve one or more prescriptions from the prescription database Hi, a patient control device, a physician control device, a physician support device, a registry and/or a portable memory device (e.g., an SD memory card) and to transmit the prescription(s) to the treatment module lib and/or the control module lie.
  • a patient control device e.g., a patient control device
  • a physician control device e.g., a physician support device
  • a registry and/or a portable memory device e.g., an SD memory card
  • the network module lid is configured to receive controller feedback data, data associated with the delivery of one or more thermal waveforms and/or data associated with the fit of one or more earpieces from the control module 11c, one or more TEDs 13a, 13b, one or more sensors 14a, 14b, a patient control device, a physician control device, a physician support device, a registry and/or a portable memory device (e.g., an SD memory card) and to transmit that data to the feedback database llj for storage.
  • the data is stored on an SD memory card inserted into an SD memory card interface.
  • the network module lid is configured to receive patient feedback data from the GUI module lie and to transmit that data to the feedback database llj for storage.
  • the patient information is stored on an SD memory card inserted into an SD memory card interface.
  • the network module lid is configured to retrieve controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces and/or patient feedback data from the feedback database llj and to transmit the data to the control module 11c, the feedback module llf, a patient control device, a physician control device, a physician support device, a registry and/or a portable memory device (e.g., an SD memory card).
  • a portable memory device e.g., an SD memory card
  • the network module lid is configured to receive patient feedback data from the GUI module lie and to transmit that data to the feedback database llj for storage.
  • the patient information is stored on an SD memory card inserted into an SD memory card interface.
  • the network module lid is configured to retrieve patient feedback data from the feedback database llj and to transmit the data to the feedback module llf, a patient control device, a physician control device, a physician support device, a registry and/or a portable memory device (e.g. , an SD memory card).
  • the network module lid is configured to receive patient information from the GUI module lie, a patient control device, a physician control device, a physician support device, a registry and/or a portable memory device (e.g., an SD memory card) and to transmit that data to the patient history database Ilk for storage.
  • the patient information is stored on an SD memory card inserted into an SD memory card interface.
  • the network module lid is configured to retrieve patient information from the patient history database I lk and to transmit the patient information to a patient control device, a physician control device, a physician support device, a registry and/or a portable memory device (e.g., an SD memory card).
  • a patient control device e.g., a physician control device
  • a physician support device e.g., a physician support device
  • a registry e.g., an SD memory card
  • FIG 16 is an illustration of a controller of the present invention.
  • the controller may comprise a graphical user interface 113 comprising an LCD display 113a configured to display data associated with the delivery of one or more thermal waveforms and a treatment start/stop button 113b whereby a patient may initiate and/or terminate a treatment session, an SD memory card interface 114 into which an SD memory card comprising a prescription may be inserted, an LED indicator light 115 configured to notify a patient of the occurrence of various events (e.g., the start of a treatment session or the generation of an alert message), a USB interface 116 configured to transmit/receive data and/or to recharge an internal power supply, a lead interface 117 whereby a patient may operatively connect one or more thermal stimulation leads and an on/off button 118.
  • a graphical user interface 113 comprising an LCD display 113a configured to display data associated with the delivery of one or more thermal waveforms and a treatment start/stop button 113b whereby a patient may initiate and/or terminate
  • FIG 17 is an illustration of another controller of the present invention.
  • the controller may comprise a graphical user interface comprising an interactive touchscreen 113c, an SD memory card interface 114 into which an SD memory card may be inserted, a USB interface 116 configured to transmit receive data and/or to recharge an internal batter supply and a lead interface 117 whereby a user may operatively connect one or more thermal stimulation leads.
  • the vestibular stimulation device may comprise one or more earpieces.
  • Earpieces of the present invention may be configured so as to be insertable into the left ear canal and/or the right ear canal of a patient.
  • Any suitable earpiece can be used to cany out the present invention, including, but not limited to, those described in U.S. Patent Publication Nos. 2010/0198204 (attorney docket number 9767-31 IP2). and 2010/0198282 (attorney docket number 9767-2IP2); in U.S. Patent Application Nos. 12/970,312 (attorney docket number 9767-3) and 12/970,347 (attorney docket number 9767-32); in United States Provisional Application Nos. 61/497,761 (attorney docket number 9767-37PR) and in United States Design Patent No. D645,455 (attorney docket number 9767-34DS), the disclosure of each of which is incorporated herein by reference in its entirety.
  • Earpieces of the present invention may comprise any suitable material, including, but not limited to, a rigid, thermally conductive material (e.g., a metal or a metal alloy).
  • a rigid, thermally conductive material e.g., a metal or a metal alloy
  • the earpiece(s) may comprise aluminum or an aluminum alloy (e.g., 6061 aluminum).
  • Earpieces of the present invention may be of any suitable size/shape.
  • the earpiece(s) comprise(s) a distal end configured so as to be insertable into the left ear canal and/or the right ear canal of a patient and a proximal end configured so as to be thermally connected to one or more TEDs.
  • each earpiece weighs between about 1 and about 10 grams (e.g., about 9 grams or less or about 4 grams or less).
  • Earpieces of the present invention may possess any suitable heat transfer properties.
  • the earpiece(s) is/are more efficiently heated than cooled.
  • the earpiece(s) may have a slew rate of about 15 degrees Centigrade per minute or greater during delivery of a cooling stimulus and a slew rate of about 20 degrees Centigrade per minute or greater during delivery of a warming stimulus.
  • Earpieces of the present invention may comprise a thermally conductive covering.
  • a thermally conductive cushion may cover one or more portions of the earpiece(s) (e.g., the portion of an earpiece that is inserted into the ear canal of a patient during use may be covered in a thermally conductive cushioning material to increase thermal contact between the earpiece and the ear canal (i.e., by conforming to the shape of the ear canal)).
  • the thermally conductive covering may comprise any suitable material, including, but not limited to, coating materials that must be reapplied to the earpiece(s) before each use (e.g., water, water-based lubricants, thermal grease, gels and the like) and reusable coating materials (e.g., a thermally conductive plastic sheath or sleeve).
  • coating materials that must be reapplied to the earpiece(s) before each use
  • reusable coating materials e.g., a thermally conductive plastic sheath or sleeve
  • Earpieces of the present invention may comprise a thermally insulating covering.
  • an insulating sleeve may cover one or more portions of the earpiece(s) (e.g. , the portion of an earpiece that remains outside the ear canal of a patient during use may be covered in an insulating sleeve to reduce heat transfer between the earpiece and the outer ear of the patient).
  • the insulating covering may comprise any suitable material, including, but not limited to, coating materials that must be reapplied to the earpiece(s) before each use (e.g., mineral oil, polypropylene, gels and the like) and reusable coating materials (e.g., a thermally insulative sheath or sleeve).
  • the thermally insulating covering comprises a silicone sleeve.
  • Earpieces of the present invention may comprise an electrically insulating covering.
  • an electrically insulating coating may cover one or more portions of the earpiece(s) (e.g., the portion of an earpiece that is inserted into the ear canal of a patient during use may be coated with an electrically insulating coating to prevent electrical conductance between the earpiece and the ear canal).
  • the electrically insulating covering may comprises any suitable material, including, but not limited to, metal oxides (e.g., aluminum oxide), glass, porcelain and composite polymer materials.
  • the surface of an earpiece comprising aluminum is anodized to produce an aluminum oxide coating that electrically insulates the surface of the earpiece.
  • Earpieces of the present invention may comprise a protective coating.
  • a protective coating may cover one or more portions of the earpiece(s) (e.g., the portion of an earpiece that is inserted into the ear canal of a patient during use may be coated with a protective coating to prevent the underlying surface of the earpiece from coming into contact with the surface of the ear canal during use).
  • the protective coating may comprise any suitable material, including, but not limited to, metals and metal alloys (gold, silver, copper and alloys thereof).
  • earpieces of the present invention may comprise a single covering/coating that fulfills multiple purposes.
  • the a thermally conductive coating applied to the portion of an earpiece that is inserted into the ear canal of a patient during use may also prevent the underlying surface of the earpiece from coming into contact with the surface of the ear canal during use.
  • earpieces of the present invention may comprise multiple coatings.
  • the earpiece(s) may comprise both a thermally conductive covering and a thermally insulative covering (e.g., a thermally conductive cushion may cover the portion of an earpiece that is inserted into the ear canal of a patient during use and an insulating sleeve may cover the portion of an earpiece that remains outside the ear canal of a patient during use).
  • an earpiece 12 of the present invention may comprise a base cavity 120, a tip cavity 121, one or more base apertures 122, and a pressure-relief channel 123.
  • the base cavity 120 may be configured to receive a TED such that the TED may be thermally coupled to the earpiece 12 by mounting the TED on an interior cavity surface of the base cavity 120.
  • the tip cavity 121 may be configured to receive a sensor (e.g., a sensor configured to detect the temperature of the earpiece).
  • a sensor e.g., a sensor configured to detect the temperature of the earpiece.
  • the base apertures 122 may be configured to provide a passageway for one or more wires and/or cables (e.g., a thermal stimulation lead connected to a TED, a wire connected to the sensor 14, etc.).
  • wires and/or cables e.g., a thermal stimulation lead connected to a TED, a wire connected to the sensor 14, etc.
  • the pressure-relief channel 123 may be configured to provide a pathway through which air and/or moisture may flow during and/or after insertion of the earpiece 12 into the ear canal of a patient (e.g., to reduce the pressure in the ear canal during and/or after insertion of the earpiece 12 and/or to allow moisture to escape the ear canal during and/or after insertion of the earpiece 12).
  • the pressure-relief channel 123 may be of any suitable length and depth (i.e., any length/depth that is sufficient to provide air flow from the interior of the ear canal at the distal tip of the earpiece to the external air outside of the ear canal during and/or after insertion of the earpiece 12).
  • the pressure-relief channel 123 may be generally as long as a side of the earpiece 12 and may be about 0.5 mm to about 2.0 mm deep.
  • the pressure-relief channel 123 may be located in any suitable location in/on the earpiece (e.g., embedded in an outer surface of earpiece 12 or passing through the interior of the earpiece 12 so as to provide a conduit between the interior of the ear canal and the exterior environment).
  • the vestibular stimulation device may comprise one or more TEDs.
  • TEDs of the present invention may be operatively connected to one or more controllers and may be used deliver one or more thermal waveforms to the vestibular system and/or the nervous system of a patient (e.g., by warming and/or cooling an earpiece inserted into the ear canal of said patient).
  • thermoelectric device can be used to carry out the present invention, including, but not limited to, those described U.S. Patent Nos. 5,974,806, 6,229,123, 6,977,360, 7,024,865, 7,098,393, 7,202,443 and 7,205,675; in U.S. Patent Publication Nos. 2004/0199266 and 2010/0198204 (attorney docket number 9767-31IP2) and 2010/0198282 (attorney docket number 9767-2IP2); in United States Patent Application Nos.
  • the vestibular stimulation device comprises one or more thin film TEDs (including, but not limited to, those described in U.S. Patent No. 6,300,150 and U.S. Patent Publication Nos. 2006/0086118 and 2007/0028956).
  • the TEDs of the present invention may comprise any suitable material.
  • the TED(s) may comprise a thermoelectric material such as bismuth telluride.
  • the TED(s) comprise a P-type thermoelectric element and an N-type thermoelectric element that are electrically coupled in series and thermally coupled in parallel.
  • the TEDs of the present invention may be of any suitable size/shape.
  • the TED(s) is/are of a generally rectangular shape, with typical rectangular areas being about 2x1 mm or about 5x2 mm or more and with a typical height profile of about 1.0 mm, about 0.65 mm or about 0.5mm or less.
  • TEDs of the present invention may be configured to sense the temperature of the earpiece(s) and/or the heat sink(s) with which it is associated.
  • the TEDs may be arranged in any suitable manner.
  • the TEDs may be positioned adjacent one another in a linear array, a two-dimensional array or a three-dimensional array (e.g., at a density of about 5, 10 or 20 per square centimeter to about 100, 200 or 400 per square centimeter or more).
  • the TEDs may be thermally coupled to one another.
  • the TEDs may be thermally coupled to one another (e.g., through a common heat sink) such that thermal energy displaced by one TED can be at least partially offset by thermal energy displaced by another TED (e.g. , by heating tissue with one TED while cooling adjacent tissue with an adjacent TED).
  • the vestibular stimulation device may comprise one or more heat sinks.
  • at least one heat sink is thermally coupled to each earpiece.
  • each TED thermally coupled to an earpiece is thermally coupled between the earpiece and at least one heat sink.
  • the heat sink(s) may be thermally isolated from the earpiece(s) except insofar as they are thermally coupled to opposite sides of the TED(s). In those embodiments comprising a pair of earpieces, each earpiece may be thermally coupled to a separate heat sink and/or to a common heat sink.
  • Any suitable heat sink can be used to carry out the present invention, including, but not limited to, those described in U.S. Patent Publication Nos. 2010/0198204 (attorney docket number 9767-31IP2) and 2010/0198282 (attorney docket number 9767-2 ⁇ 2); in United States Patent Application Nos. 12/970,312 (attorney docket number 9767-3) and 12/970,347 (attorney docket number 9767-32) and in United States Provisional Application No. 61/497,761 (attorney docket number 9767-37P ), the disclosure of each of which is incorporated herein by reference in its entirety.
  • Heat sinks of the present invention may comprise any suitable material, including, but not limited to, metal alloys.
  • the heat sink(s) may comprise aluminum or an aluminum alloy (e.g., 6061 aluminum).
  • Heat sinks of the present invention may be of any suitable size/shape.
  • the heat sink(s) comprise(s) a plurality of fins.
  • Such fins may be from about 1 to about 500 mm in height, preferably about 1 to about 100 mm.
  • each heat sink weighs between about 30 grams and about 70 grams.
  • Heat sinks of the present invention may be passively and/or actively cooled.
  • each heat sink may be associated with one of more fans configured to increase air flow over the heat sink, thereby facilitating heat dissipation from the heat sink.
  • the vestibular stimulation device may comprise one or more sensors.
  • the sensor(s) is/are configured to transmit controller feedback data, data associated with the delivery of one or more thermal waveforms to the vestibular system and /or the nervous system of a patient and/or data associated with the fit of one or more earpieces to the controller.
  • the controller is configured (e.g., with computer instructions (i.e., software)) to adjust one or more attributes of TED activation (e.g., magnitude, duration, wave pattern, etc.) in response to feedback data received from the sensor(s) with which it is associated.
  • the sensor(s) may be configured to transmit data to the controller over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • Any suitable sensor can be used to carry out the present invention, including, but not limited to, those described in U.S. Patent Nos. 7,578,793, 7,558,622, 7,396,330, 7,215,994, 7,197,357, 7,087,075 and 6,467,905; in U.S. Patent Publication No. 2010/0198282 (attorney docket number 9767-2IP2); in U.S. Patent Application Nos. 12/970,312 (attorney docket number 9767-3) and 12/970,347 (attorney docket number 9767-32) and in United States Provisional Application No.
  • the vestibular stimulation device may comprise one or more of a galvanic skin resistance sensor, a position sensor, a motion detector, a blood pressure sensor, a heart rate sensor, a blood gas level sensor, an electrocardiogram sensor, an electroencephalogram sensor, an electrooculogram sensor, an electronystragmography sensor, a breathing rate sensor, a nystagmus sensor and a temperature sensor.
  • a galvanic skin resistance sensor a position sensor, a motion detector, a blood pressure sensor, a heart rate sensor, a blood gas level sensor, an electrocardiogram sensor, an electroencephalogram sensor, an electrooculogram sensor, an electronystragmography sensor, a breathing rate sensor, a nystagmus sensor and a temperature sensor.
  • the vestibular stimulation device comprises one or more temperature sensors.
  • the vestibular stimulation device comprises a temperature sensor configured to provide controller feedback data associated with the temperature of the heat sink, a temperature sensor configured to provide controller feedback data associated with the temperature of the earpiece, a temperature sensor configured to provide controller feedback data associated with the temperature of the ear canal of the patient and/or a temperature sensor configured to provide controller feedback data associated with the temperature of the inner ear of the patient.
  • each earpiece comprises a sensor (e.g., an infrared sensor) configured to detect the temperature of the inner ear.
  • the vestibular stimulation device may comprise a headband.
  • the headband is configured to position the earpiece(s) in the ear canal(s) of a patient.
  • the headband is adjustable. It should be appreciated that, while the headband may be worn over the head, it may also be positioned under the chin, behind the head and/or over the ear(s).
  • Any suitable headband can be used to carry out the present invention, including, but not limited to, those described in United States Patent Application Nos. 12/704,872; 12/970,312 (attorney docket number 9767-3) and 12/970,347 (attorney docket number 9767-32) and in United States Provisional Application Nos.
  • the vestibular stimulation device 1 may comprise a controller 11 that is operatively connected to a TED 13a that is thermally connected to an earpiece 12a that is configured so as to be insertable into the left ear canal of a patient and to a TED 13b that is thermally connected to an earpiece 12b that is configured so as to be insertable into the right ear canal of a patient.
  • the controller 11 e.g., a controller 11 as described above with respect to Figure 14
  • the controller 11 is configured to enable a user to deliver one or more thermal waveforms to the vestibular system and/or the nervous system of a patient by:
  • treatment module lib and/or storing the generated/modified parameters, indications and/or approvals in the waveform database llh;
  • thermal waveforms to the vestibular system and/or the nervous system of the patient by:
  • a prescription comprising a set of instructions for delivering one or
  • the controller 11 (e.g., a controller 11 as described above with respect to Figure 15) is configured to enable a user to deliver one or more thermal waveforms to the vestibular system and/or the nervous system of a patient by:
  • thermal waveforms from a patient control device, a physician control device, a physician support device, a registry and/or a portable memory device using the network module lid; storing the received/retrieved parameters, indications and/or approvals in the waveform database llh and/or transmitting the received/retrieved parameters, indications and/or approvals to the waveform module 11a and/or the treatment module lib;
  • generating a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of the patient by: i) receiving one or more thermal waveforms from the network module lid and/or the waveform module 11a and providing instructions as to how each thermal waveform is to be administered to the patient using the treatment module lib; ii) selecting one or more thermal waveforms from the waveform database llh and providing instructions as to how each thermal waveform is to be administered to the patient using the treatment module lib;
  • a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular .system and/or the nervous system of the patient from the treatment module lib and activating the TEDs 13a, 13b in accordance with the instructions; or
  • a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of the patient from the prescription database Hi and activating the TEDs 13a, 13b in accordance with the instructions.
  • the vestibular stimulation device 1 may further comprise a pair of sensors 14a, 14b, wherein one of the sensors 14a is operatively connected to the earpiece 12a that is configured so as to be insertable into the left ear canal of the patient, wherein the other sensor 14b is operatively connected to the earpiece 12b that is configured so as to be insertable into the right ear canal of the patient and wherein the controller 11 is operatively connected to each of the sensors 14a, 14b via a wireless connection 17a, 17b.
  • controller 11 e.g. , a controller 11 as described above with respect to Figure 15
  • controller feedback data received from the sensors e.g.
  • control module 11c data associated with the temperature of the earpiece(s), data associated with the temperature of the patient's ear canal(s), data associated with the rate at which an earpiece is warmed/cooled in response to a warming/cooling stimulus, etc. is used by the control module 11c to ensure that the appropriate thermal waveform(s) is delivered to the vestibular system and/or the nervous system of the patient (e.g., the control module 11c may be configured to increase/decrease the magnitude of TED 13a activation if/when controller feedback data from the sensor 14b associated with the left earpiece 12a indicates that the temperature of the earpiece 12a is not at the appropriate temperature given the parameters of the prescribed thermal waveform).
  • the vestibular stimulation device comprises a controller 11 and a headset 18.
  • the headset may comprise a headband 18h configured to position a first earpiece 12a in the left ear canal of a patient and to position a second earpiece 12b in the right ear canal of the subject; a first heat sink thermally coupled to the first earpiece 12a (as shown, the first heat sink is concealed within a first housing 18a, the ventilation apertures 18av of which allow for heat exchange between the first heat sink and the ambient environment), a second heat sink thermally coupled to the second earpiece 12b (as shown, the first heat sink is concealed within a second housing 18b, the ventilation apertures 18bv of which allow for heat exchange between the second heat sink and the ambient environment); a first TED thermally coupled between the first earpiece 12a and the first heat sink (as shown, the first TED is concealed within the first housing 18a); a second TED 13b thermally coupled between the second earpiece 12
  • the controller is operatively connected to the first and second TEDs by a pair of thermal stimulation leads 16a, 16b.
  • the controller 11 is operatively connected to the first and second sensors via a wireless connection (e.g., via a radiofrequency transceiver or a Bluetooth connection).
  • one or both of the first and second cushions 18c, 18d is configured to be adjustable (e.g., the first cushion 18c and/or the second cushion 18d may comprise an inner chamber that may be inflated/deflated to adjust the firmness and/or the size of the cushion, thereby allowing a user to adjust the fit of the vestibular stimulation device (i.e. , to adjust how far the first and/or second earpiece 12a, 12b inserts into the patient's ear canal by increasing/decreasing the amount of gas/liquid in the inner chamber)).
  • FIG. 20 provides an exploded view of a first housing 18a according to some embodiments of the present invention.
  • the first housing 18a may conceal a first TED 13a; a first sensor 14a; a first heat sink 15a, said first heat sink 15a comprising a first heat sink base 15ab, a first heat sink spacer 18as, a plurality of fins 15af and a plurality of cable apertures 15ac to provide passageways for one or more wires and/or cables (e.g.
  • the first earpiece 12a may be thermally connected to the first TED 13a and the first heat sink 15a as shown in Figures 21A-21B.
  • the first TED 13a may be positioned on the top surface 15as' of the heat sink spacer 15as and inside the base cavity 120a of the first earpiece 12a and may be adhered to the heat sink 15a and/or the first earpiece 12a using a thermally conductive adhesive (e.g., silver paste).
  • a thermally conductive adhesive e.g., silver paste
  • the first sensor 14a may be positioned inside the tip cavity 121 of the first earpiece 12a and may be configured to provide controller feedback data associated with the temperature of the first earpiece 12a to the controller (as discussed above).
  • the heat dissipating fans 19a, 19b may facilitate the transfer of heat between the first heat sink 15a and the ambient environment by increasing air flow across the first heat sink 15a.
  • the outer member 18ao of the first housing 18a comprises ventilation apertures 18av to further facilitate the transfer of heat between the first heat sink 15a and the ambient environment (by increasing the flow of air across the first heat sink 15a) and a cable aperture 18ac to provide a passageway for one or more wires and/or cables (e.g.
  • the inner member 18ai of the first housing 18a comprises an earpiece aperture 18ae through which the distal portion of the first earpiece 12a protrudes.
  • the second housing 18b may be similarly configured.
  • the present invention provides a physician control device for generating and/or modifying the parameters, indications and/or approvals of one of more thermal waveforms; for generating, modifying, updating and/or extending one or more prescriptions and/or for receiving, analyzing and/or transmitting data.
  • the physician control device is configured to generate a prescription comprising instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient and to transmit the prescription to a vestibular stimulation device (e.g., a vestibular stimulation device of the present invention) and/or a patient control device (e.g. , a patient control device of the present invention).
  • a vestibular stimulation device e.g., a vestibular stimulation device of the present invention
  • a patient control device e.g. , a patient control device of the present invention
  • the physician control device comprises, consists essentially of or consists of a treatment module configured to generate a prescription and a network module configured to transmit the prescription to a vestibular stimulation device and/or a patient control device.
  • a physician control device of the present invention may be any suitable computing device/system, including, but not limited to, a desktop computer, a laptop computer, a handheld computer, a personal digital assistant (PDA), and a smart phone.
  • a desktop computer including, but not limited to, a desktop computer, a laptop computer, a handheld computer, a personal digital assistant (PDA), and a smart phone.
  • PDA personal digital assistant
  • physician control device Any conventional security means may be provided to prevent unauthorized activation of the physician control device.
  • the physician control device may be password protected.
  • the physician control support device may be configured to receive and/or transmit and suitable data, including, but not limited to, data associated with the parameters, indications and/or approvals of one or more thermal waveforms, data associated with one or more prescriptions, controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and/or patient information.
  • the physician control device may be configured to receive and/or transmit data from/to various devices, including, but not limited to, a vestibular stimulation device, a patient control device, a physician support device, a registry, a TED, a sensor and/or a portable memory device (e.g., an SD memory card).
  • the physician control device is configured to receive data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g.
  • idealized thermal waveforms from a physician support device, a registry and/or a portable memory device (e.g., an SD memory card); to transmit data associated with the parameters, indications and/or approvals of one or more thermal waveforms ⁇ e.g., idealized thermal waveforms) to a vestibular stimulation device, a patient control device, a registry and/or a portable memory device (e.g., an SD memory card); to receive one or more prescriptions from a physician support device, a registry and/or a portable memory device (e.g., an SD memory card); to transmit one or more prescriptions to a vestibular stimulation device, a patient control device, a registry and/or a portable memory device (e.g., an SD memory card); to receive one or more prescription modifications, updates and/or extensions from a physician support device, a registry and/or a portable memory device (e.g., an SD memory card); to transmit one or more prescription modifications, updates and/or extensions to a vestibular stimulation device,
  • the physician control device may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the physician control device comprises memory, a processor and a power supply.
  • the processor may be any commercially available or custom microprocessor.
  • Memory can include, but is not limited to, the following types of devices: cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.
  • the power supply may be an internal power supply (e.g., one or more rechargeable batteries that may be recharged without first being removed from the physician control device).
  • the physician control device 's memory may comprise any suitable software and/or data, including, but not limited to, an operating system, applications, data and input/output (I/O) drivers.
  • physician control device may use any suitable operating system, including, but not limited to, OS/2, ALX, OS/390 or System390 from International Business
  • the physician control device may comprise any suitable application, including, but not limited to, one or more programs configured to implement one or more of the various features of the present invention.
  • the physician control device may comprise a waveform module that enables a user to generate and/or modify the parameters, indications and/or approvals of one or more thermal waveforms; a treatment module that enables a user to generate, modify, update and/or extend a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient; a network module configured to receive and/or transmit data; a GUI module configured to display information and/or accept user input; a feedback module configured to receive, transmit, and/or analyze data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and/or patient information; an alert generation module configured to generate one or more alert messages; a tone generation module configured to produce one
  • the physician control device may comprise a waveform-treatment module that enables a user to generate and/or modify one or more thermal waveforms and to generate, modify, update and/or extend a prescription).
  • one of the aforementioned modules is split into two or more distinct modules (e.g., the physician control device may comprise a waveform generation module that enables a user to generate the parameters, indications and/or approvals of one or more thermal waveforms and a waveform update module that enables a user to modify the parameters, indications and/or approvals of one or more thermal waveforms).
  • one or more of the functions described below with respect to one of the modules described below is performed by one of the other modules described below (e.g., the treatment module, rather than the waveform module, may be configured to modify the parameters, indications and/or approvals of one or more thermal waveforms).
  • the treatment module rather than the waveform module, may be configured to modify the parameters, indications and/or approvals of one or more thermal waveforms.
  • the waveform module may be configured to modify the parameters, indications and/or approvals of one or more thermal waveforms.
  • the physician control device comprises a waveform module whereby a user may generate and/or modify the parameters, indications and/or approvals of one or more thermal waveforms.
  • the waveform module comprises software that enables a user to generate and/or modify the parameters of one or more thermal waveforms by point-to-point design and/or by utilizing mathematical functions.
  • the waveform module may comprise software that enables a user to generate and/or modify the parameters, indications and/or approvals of a thermal waveform by selecting altering one or more parameters, including, but not limited to, shape, frequency, amplitude and duration.
  • the waveform module enables a user to retrieve/select a thermal waveform from a database and then modify the parameters of that thermal waveform to generate a new thermal waveform.
  • the waveform module comprises software that enables a user to generate and/or modify the parameters, indications and/or approvals of one or more thermal waveforms using an interactive touch screen.
  • the waveform module may comprise software that enables a user to generate the parameters of a thermal waveform by drawing the desired waveform on an interactive touch screen (as discussed above with respect to Figure 3).
  • the waveform module may enable a user to modify the parameters of a thermal waveform by highlighting one or more points on the waveform and moving the point(s) to a new location (e.g., a higher/lower temperature) (as discussed above with respect to Figure 4).
  • the waveform module comprises software that automatically adjusts the parameters of the thermal waveform(s) created by a user to account for system limitations.
  • the waveform module may comprise software that automatically adjusts the slope of a thermal waveform in accordance with the minimum/maximum temperature and/or the rate of temperature change that is achievable using a particular combination of earpiece(s), TED(s), etc. That is, the waveform module may comprise software that prevents a user from generating parameters for a thermal waveform that cannot be delivered because of system limitations.
  • the waveform module comprises software that enables a user to protect one or more thermal waveforms (i.e., to prevent one or more users from modifying the parameters, indications and/or approvals of the thermal waveform(s) and/or from deleting the thermal waveform(s) from a waveform database).
  • the waveform module may comprise software that enables a user to protect one or more idealized thermal waveforms (e.g., by requiring users to enter a specified password prior to modifying and/or deleting the idealized thermal waveform(s)).
  • the waveform module comprises software that enables a user to remove the protected status from one or more thermal waveforms.
  • the waveform module may comprise software that enables a user to remove the protected status from one or more idealized thermal waveforms (e.g., by entering the appropriate password).
  • the waveform module is configured to automatically generate and/or modify the parameters, indications and/or approvals of one or more thermal waveforms (e.g., idealized thermal waveforms) in response to data received from one or more devices/modules.
  • the waveform module may be configured to automatically update one or more thermal waveforms responsive to data received from one or more TEDs and/or one or more sensors.
  • the waveform module may be configured to retrieve the parameters, indications and/or approvals of one or more thermal waveforms from any suitable database, including, but not limited to, a waveform database residing in a vestibular stimulation device, a waveform database residing in a patient control device, a waveform database residing in the physician control device, a waveform database residing in a physician support device, a waveform database residing in a registry and/or a waveform database residing in a portable memory device (e.g., an SD memory card).
  • a portable memory device e.g., an SD memory card
  • Waveform parameters, indications and/or approvals generated and/or modified by the waveform module may be stored in a database.
  • the generated/modified parameters, indications and/or approvals are stored in a waveform database comprising data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g., idealized thermal waveforms).
  • the generated/modified waveform parameters, indications and/or approvals may be stored in a waveform database residing in a vestibular stimulation device, a waveform database residing in a patient control device, a waveform database residing in the physician control device, a waveform database residing in a physician support device, a waveform database residing in a registry and/or a waveform database residing in a portable memory device (e.g., an SD memory card).
  • a portable memory device e.g., an SD memory card
  • the physician control device comprises a treatment module whereby a user (e.g., a physician) may generate, modify, update and/or extend a prescription.
  • a user e.g., a physician
  • the treatment module may enable a user to generate, modify, update and/or extend a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • the treatment module comprises software that enables a user to select one or more thermal waveforms from a database (e.g. , an idealized thermal waveform from an idealized waveform database) and to provide instructions as to when/how each of those waveforms should be administered.
  • a database e.g. , an idealized thermal waveform from an idealized waveform database
  • a treatment module may comprise software that enables a user to provide instructions as to how long a treatment schedule is to last (as discussed above with respect to Figure 5), to provide instructions as to how many treatments may be administered each day (as discussed above with respect to Figure 5), to provide instructions as to how often each thermal waveform is to be administered (as discussed above with respect to Figure 6), to provide instructions as to what time(s) of day each thermal waveform is to be administered (as discussed above with respect to Figure 6 and 9), to select one or more idealized thermal waveforms from a database (as discussed above with respect to Figure 7), to provide instructions regarding whether each of the selected thermal waveforms is to be delivered to the right and/or left ear canal of a patient (as discussed above with respect to Figure 8), etc.
  • the treatment module comprises software that enables a user to modify, update and/or extend a prescription by changing one or more parameters of the prescription (as discussed above with respect to Figure 10), including, but not limited to, which thermal waveform(s) are delivered, frequency with which the thermal waveform(s) is/are delivered, and the expiration date of the prescription.
  • Any suitable prescription may be modified, updated and/or extended, including, but not limited to, prescriptions stored in a prescription database (e.g., a prescription database residing in a vestibular stimulation device, in a patient control device, in the physician control device, in a physician support device or in a portable memory device, such as a portable SD memory card).
  • the treatment module may be configured to retrieve/select thermal waveforms from any suitable database, including, but not limited to, a waveform database residing in a vestibular stimulation device, a waveform database residing in a patient control device, a waveform database residing in the physician control device, a waveform database residing in a physician support device, a waveform database residing in a registry and/or a waveform database residing in a portable memory device (e.g. , an SD memory card).
  • a portable memory device e.g. , an SD memory card
  • the treatment module may be configured to retrieve prescriptions from any suitable database, including, but not limited to, a prescription database residing in a vestibular stimulation device, a prescription database residing in a patient control device, a prescription database residing in the physician control device, a prescription database residing in a physician support device, a prescription database residing in a registry and/or a prescription database residing in a portable memory device (e.g., an SD memory card).
  • a prescription database residing in a vestibular stimulation device e.g., a prescription database residing in a patient control device
  • a prescription database residing in the physician control device e.g., a prescription database residing in a physician support device
  • a prescription database residing in a registry e.g., an SD memory card
  • Prescriptions generated, modified, updated and/or extended by the treatment module may be added to a database comprising one or more prescriptions.
  • the prescriptions may be stored in a prescription database residing in a vestibular stimulation device, a prescription database residing in a patient control device, a prescription database residing in the physician control device, a prescription database residing in a physician support device, a prescription database residing in a registry and/or a prescription database residing in a portable memory device.
  • the physician control device comprises a network module configured to receive, retrieve and/or transmit data.
  • the network module may be configured to receive, retrieve and/or transmit data from/to any suitable device/module/database, including, but not limited to, other modules residing in the physician control device, databases residing in the physician control device, a vestibular stimulation device, a patient control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • a suitable device/module/database including, but not limited to, other modules residing in the physician control device, databases residing in the physician control device, a vestibular stimulation device, a patient control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • the network module may be configured to receive, retrieve and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the network module may be configured to receive, retrieve and/or transmit any suitable data, including, but not limited to, data associated with the parameters, indications and/or approvals of one or more thermal waveforms, one or more prescriptions, controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and/or patient information.
  • data associated with the parameters, indications and/or approvals of one or more thermal waveforms, one or more prescriptions controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and/or patient information.
  • the network module is configured to receive and/or retrieve data associated with the parameters, indications and/or approvals of one or more thermal waveforms from a waveform module/database residing in the physician control device, from a vestibular stimulation device, from a patient control device, from a physician support device, from a registry and/or from a portable memory device.
  • the network module is configured to receive and/or retrieve one or more prescriptions from a treatment module residing in the physician control device, from a prescription database residing in the physician control device, from a vestibular stimulation device, from a patient control device, from a physician support device, from a registry and/or from a portable memory device.
  • the network module is configured to receive and/or retrieve controller feedback data, data associated with the delivery of one or more thermal waveforms and/or data associated with the fit of one or more earpieces from a feedback module/database residing in the physician control device, from a vestibular stimulation device and/or from a patient control device.
  • the network module is configured to receive and/or retrieve patient feedback data, physician feedback data and/or patient information from a feedback module/database residing in the physician control device, from a GUI module residing in the physician control device, from a patient information database residing in the physician control device, from a vestibular stimulation device, from a patient control device, from a physician support device, from a registry and/or from a portable memory device.
  • the network module is configured to transmit data associated with the parameters, indications and/or approvals of one or more thermal waveforms to a waveform module/database residing in the physician control device, to a treatment module residing in the physician control device, to a vestibular stimulation device, to a patient control device, to a physician support device, to a registry and/or to a portable memory device.
  • the network module is configured to transmit one or more prescriptions to a treatment module residing in the physician control device, to a prescription database residing in the physician control device, to a vestibular stimulation device, to a patient control device, to a physician support device, to a registry and/or to a portable memory device.
  • the network module is configured to transmit controller feedback data, data associated with the delivery of one or more thermal waveforms and/or data associated with the fit of one or more earpieces to a feedback module/database residing in the physician control device, to a vestibular stimulation device, to a patient control device, to a physician support device, to a registry and/or to a portable memory device.
  • the network module is configured to transmit patient feedback data, physician feedback data and/or patient information to a feedback module/database residing in the physician control device, to a patient information database residing in the physician control device, to a vestibular stimulation device, to a patient control device, to a physician support device, to a registry and/or to a portable memory device.
  • the network module is configured to access a database comprising data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g. , idealized thermal waveforms).
  • the network module maybe configured to access a waveform database residing in a vestibular stimulation device, a waveform database residing in a patient control device, a waveform database residing in the physician control device, a waveform database residing in a physician support device, a waveform database residing in a registry and/or a waveform database residing in a portable memory device.
  • the network module is configured to access a database comprising one or more prescriptions.
  • the network module maybe configured to access a prescription database residing in a vestibular stimulation device, a prescription database residing in a patient control device, a prescription database residing in the physician control device, a prescription database residing in a physician support device, a prescription database residing in a registry and/or a prescription database residing in a portable memory device.
  • the network module is configured to access a database comprising controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data and/or physician feedback data.
  • the network module maybe configured to access a feedback database residing in a vestibular stimulation device, a feedback database residing in a patient control device, a feedback database residing in the physician control device, a feedback database residing in a physician support device, a feedback database residing in a registry and/or a feedback database residing in a portable memory device.
  • the network module is configured to access a database comprising patient information.
  • the network module maybe configured to access a patient information database residing in a vestibular stimulation device, a patient information database residing in a patient control device, a patient information database residing in the physician control device, a patient information database residing in a physician support device, a patient information database residing in a registry and/or a patient information database residing in a portable memory device.
  • the physician control device comprises a GUI module configured to display information and/or to accept user input.
  • GUI Any suitable GUI may be used, including, but not limited to, a keyboard, a mouse, an LCD display with one or more associated entry keys and an interactive touch screen.
  • the GUI may comprise a static pressure touch-sensitive display, a capacitive touch-sensitive display, a resistive touch- sensitive display, an electrostatic capacity proximity sensor, a magnetic proximity sensor and /or an infrared proximity sensor. See, e.g., U.S. Patent Publication Nos. 2011/0271222, 2011/0273575, 2011/0275414 and 2011/0275416.
  • the GUI module may be configured to display any suitable information, including, but not limited to, data associated with the delivery of one or more thermal waveforms.
  • the GUI module may be configured to display the current date and/or time (as discussed above with respect to Figure 10); one or more target temperatures (as discussed above with respect to Figure 11); the number of treatment sessions that have been administered for a prescription; the number of treatment sessions remaining in a prescription; the amount of time remaining until a prescription must be renewed/updated; the amount of remaining battery life, an alert message (e.g., a reminder to a physician that he/she needs to modify, update and/or extend a prescription); the target time/temperature parameters of one or more prescribed thermal waveform(s) (as discussed above with respect to Figure 11); the precise time/temperature parameters of the thermal waveform(s) delivered to a patient; the date/time of delivery of the thermal waveform(s) delivered to a patient; the temperature(s) of a patient's ear canal(s) at various time points before, during
  • videos/images of a patient that may be used to assess mood
  • objectives measures of efficacy e.g., nystamography data, EEG data, MRI data, heart rate data, blood pressure data
  • subjective measures of efficacy e.g., a patient-reported pain score
  • blood chemistry data e.g., blood Ale levels, blood glucose levels and blood Cortisol levels
  • saliva chemistry data e.g., saliva Cortisol levels
  • urine chemistry data e.g., urine Cortisol levels
  • comments a patient made about his/her treatment session(s) e.g.
  • comments made to a physician, submitted in response to an automated survey and/or recorded in a treatment diary ); the impedance between an earpiece inserted into the ear canal of a patient and an electrode affixed to a second location on/in said patient's body (e.g., an electrode placed in or adjacent to the patient's other ear canal); the rate at which a patient's inner ear cools in response to a cooling stimulus (e.g., data from a temperature sensor, such as thermistor, that monitors how quickly the inner ear cools in response to a cooling waveform); the rate at which a patient's inner ear warms in response to a warming stimulus (e.g. , data from a temperature sensor, such as thermistor, that monitors how quickly the inner ear warms in response to a warming waveform) and/or patient comments regarding the subjective fit of his/her earpiece(s).
  • a cooling stimulus e.g., data from a temperature sensor, such as thermistor,
  • the GUI module may be configured to accept any suitable user input, including, but not limited to, instructions for generating and/or modifying the parameters, indications and/or approvals of a thermal waveforms; instructions for generating, modifying, updating and/or extending a prescription; physician feedback and/or patient information.
  • the GUI module may be configured to accept a physician comments regarding the effectiveness of a particular combination of thermal waveforms.
  • the physician control device comprises a feedback module configured to receive, transmit and/or analyze data.
  • the feedback module may be configured to receive and/or transmit data from/to any suitable device/module/database, including, but not limited to, other modules residing in the physician control device, databases residing in the physician control device, a vestibular stimulation device, a patient control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • a suitable device/module/database including, but not limited to, other modules residing in the physician control device, databases residing in the physician control device, a vestibular stimulation device, a patient control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • the feedback module may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the feedback module may be configured to receive, transmit and/or analyze any suitable data, including, but not limited to, controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and/or patient information.
  • the feedback module is configured to receive and/or analyze data associated with the delivery of one or more thermal waveforms and/or data associated with the fit of one or more earpieces from a feedback database residing in the physician control device, from one or more vestibular stimulation devices and/or from one or more patient control devices.
  • the feedback module may be.
  • the fit of an earpiece based upon the rate at which the temperature of the earpiece changes in response to a cooling/warming waveform, the slew rate associated with one or more TEDs, the impedance between an earpiece positioned in the left ear canal of a patient and an earpiece positioned in the right ear canal of a patient, the impedance between an earpiece positioned in the ear canal of a patient and an electrode affixed to a second location on/in the patient's body, etc.
  • the feedback module is configured to receive and/or analyze patient feedback data, physician feedback data and/or patient information from a GUI module residing in the physician control device, from a feedback database residing in the physician control device, from a patient information database residing in the physician control device, from a vestibular stimulation device, from a patient control device, from a physician support device and/or from a portable memory device.
  • the feedback module may be configured to analyze the effectiveness of a given thermal waveform or combination of thermal waveforms (e.g., by analyzing pain scores entered before, during and after a treatment session), the effect(s) of one or more waveform modifications (e.g., by analyzing whether/how much a given waveform modification changed the effectiveness of a thermal waveform in treating a disease/disorder), etc.
  • the feedback module is configured to transmit data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data, patient information and/or data associated with its analysis to a feedback database residing in the physician control device, to a patient information database residing in the physician control device, to a physician support device, to a registry and/or to a portable memory device (e.g., an SD memory card).
  • a portable memory device e.g., an SD memory card
  • the physician control device comprises an alert generation module configured to generate one or more alert messages.
  • the alert generation module may be configured to generate any suitable alert message, including, but not limited to, a reminder that a patient is due for a prescription refill; an alert indicating that one or more idealized thermal waveforms has been modified; an alert indicating that a given modification is likely to increase/decrease the effectiveness of a given thermal waveform and/or an alert indicating that a given thermal waveform, class of thermal waveforms or combination of thermal waveforms has been identified as being indicated and/or approved for use in the treatment of a disease/disorder and a warning that the physician control device's internal power supply is low.
  • any suitable alert message including, but not limited to, a reminder that a patient is due for a prescription refill; an alert indicating that one or more idealized thermal waveforms has been modified; an alert indicating that a given modification is likely to increase/decrease the effectiveness of a given thermal waveform and/or an alert indicating that a given thermal waveform, class of thermal waveforms or combination of thermal waveforms has been identified as being indicated and/
  • the alert generation module is configured to communicate with various devices/modules, including, but not limited to, a vestibular stimulation device, a patient control device, a physician support device, a registry, a TED, a sensor, a portable memory device (e.g., an SD memory card) and other modules of the physician control device.
  • the alert generation module may be configured to provide instructions to the GUI module and/or the tone generation module for displaying one or more alert messages and/or for generation an audible tone to alert a user of the presence of the one or more alert messages.
  • the graphical user interface module may be configured to display the one or more alert messages immediately upon generation or upon interaction with a user (e.g., an alert notification icon may be generated, with the alert message being displayed only after the user indicates that he/she wishes to view the message).
  • an alert notification icon may be generated, with the alert message being displayed only after the user indicates that he/she wishes to view the message.
  • the physician control device comprises a tone generation module configured to produce audible tones.
  • the tone generation module comprises a piezo buzzer.
  • Audible tones may be produced to alert a user to various circumstances/events, including, but not limited to, the existence of an unread/unviewed alert message. Audible tones may be generated repeatedly in response to a single circumstance/event (e.g., an audible tone may be generated repeatedly until the user views/reads the message) and may become progressively louder and/or more frequent with time.
  • the physician control device comprises a visual indicator module configured to notify a user of the existence of an unread/unviewed alert message.
  • the visual indicator module comprises an LED indicator light.
  • the visual indicator module may be activated repeatedly in response to a single alert message (e.g. , an LED light may be illuminated repeatedly until the user views/reads the message) or may remain activated until the user views/reads the message.
  • the physician control device comprises a security module configured to prevent unauthorized use of the physician control device (i.e., to prevent unauthorized persons from using the physician control device, to prevent authorized persons from using the physician control device in an unauthorized manner, etc.).
  • the security module may be configured to prevent unauthorized use of the physician control device using any suitable means of security, including, but not limited to, password protection and data encryption.
  • the security module may be configured such that a user is required to input a designated password prior to generating and/or modifying a thermal waveform; generating, modifying, updating and/or extending a prescription; entering viewing patient feedback data; entering/viewing physician feedback data and/or entering/viewing patient information (as discussed above with respect to Figure 12).
  • the physician control device may comprise any suitable data, including, but not limited to, static and/or dynamic data used by the operating system, applications, I/O device drivers and other software components, controller feedback data, data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g., idealized thermal waveforms), data associated with one or more prescriptions, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and patient information.
  • thermal waveforms e.g., idealized thermal waveforms
  • the physician control device may comprise a waveform database comprising data associated with one or more idealized thermal waveforms; a prescription database comprising data associated with one or more prescriptions; a feedback database comprising controller feedback data, data associated with the delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of a patient, patient feedback data and physician feedback data and/or a patient history database comprising data associated with one or more patients.
  • a waveform database comprising data associated with one or more idealized thermal waveforms
  • a prescription database comprising data associated with one or more prescriptions
  • a feedback database comprising controller feedback data, data associated with the delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of a patient, patient feedback data and physician feedback data and/or a patient history database comprising data associated with one or more patients.
  • a feedback database comprising controller feedback data, data associated with the delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of a patient, patient feedback
  • one of the aforementioned databases is split into two or more distinct databases (e.g. , the physician control device may comprise a delivery feedback database comprising data associated with the specific parameters of the thermal waveform(s) delivered to a patient, a patient feedback database comprising patient feedback data and a physician feedback database comprising physician feedback data).
  • the physician control device may comprise a delivery feedback database comprising data associated with the specific parameters of the thermal waveform(s) delivered to a patient, a patient feedback database comprising patient feedback data and a physician feedback database comprising physician feedback data).
  • one or more of the data types described below with respect to one of the databases described below is stored in one of the other databases described below (e.g., the patient information database, rather than the feedback database, may be configured to receive/store patient feedback data).
  • data is transmitted, received and/or stored in a controlled format (e.g., in a standardized format using forms/programs supplied by a physician support device or a registry).
  • the physician control device may be configured to transmit, receive and store data in a manner that ensures compliance with any and all applicable laws and/or regulations (e.g., the Health Insurance Portability and Accountability Act of 1996 (P.L. 104-191 ; "HIP AA”)).
  • any and all applicable laws and/or regulations e.g., the Health Insurance Portability and Accountability Act of 1996 (P.L. 104-191 ; "HIP AA"
  • the physician control device comprises a waveform database configured to receive, store and/or transmit data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g, one or more idealized thermal waveforms).
  • the waveform database is configured such that one or more of the thermal waveforms stored therein is/are protected (e.g., users may be prevented from modifying and/or deleting the idealized thermal waveform(s) stored in the waveform database).
  • the waveform database may comprise any suitable type of memory including, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.
  • the waveform database comprises a portable memory device, such as an SD memory card or a USB memory stick.
  • the waveform database may comprise an SD memory card interface and one or more prescriptions may be stored on a portable SD memory card.
  • the waveform database may be configured to receive and/or transmit data from/to any suitable device/module/database, including, but not limited to, modules residing in the physician control device, a vestibular stimulation device, a patient control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • modules residing in the physician control device including, but not limited to, modules residing in the physician control device, a vestibular stimulation device, a patient control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • the waveform database may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the physician control device comprises a prescription database configured to receive, transmit and/or store one or more prescriptions, wherein each prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • the prescription database may comprise any suitable type of memory including, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.
  • the prescription database comprises a portable memory device, such as an SD memory card or a USB memory stick.
  • the prescription database may comprise an SD memory card interface and one or more prescriptions may be stored on a portable SD memory card.
  • the prescription database may be configured to receive and/or transmit data from/to any suitable device/module/database, including, but not limited to, modules residing in the physician control device, a vestibular stimulation device, a patient control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • modules residing in the physician control device including, but not limited to, modules residing in the physician control device, a vestibular stimulation device, a patient control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • the prescription database may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the physician control device comprises a feedback database configured to receive, transmit and/or store feedback data.
  • the feedback database may comprise any suitable type of memory including, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.
  • the feedback database comprises a portable memory device, such as an SD memory card or a USB memory stick.
  • the feedback database may comprise an SD memory card interface and one or more prescriptions may be stored on a portable SD memory card.
  • the feedback database may be configured to receive and/or transmit feedback data from/to any suitable device/module/database, including, but not limited to, modules residing in the physician control device, a vestibular stimulation device, a patient control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • modules residing in the physician control device including, but not limited to, modules residing in the physician control device, a vestibular stimulation device, a patient control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • the feedback database may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • Feedback data may comprise any suitable data, including, but not limited to, controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and/or patient information.
  • the feedback database may comprise a log file detailing the target time/temperature parameters of one or more prescribed thermal waveform(s); the time/temperature parameters of the thermal waveform(s) delivered to a patient; the date/time of delivery of the thermal waveform(s) delivered to a patient; the temperature(s) of a patient's ear canal(s) at various time points before, during and/or after delivery of one or more thermal waveforms; the temperature(s) of a patient's inner ear(s) at various time points before, during and/or after delivery of one or more thermal waveforms; the fit of one or more earpieces at various time points before, during and/or after delivery of one or more thermal waveforms; an estimate of the thermal contact between one or more earpieces and a
  • the physician control device comprises a patient history database configured to receive, transmit and/or store patient information.
  • the patient history database may comprise any suitable type of memory including, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.
  • the patient history database comprises a portable memory device, such as an SD memory card or a USB memory stick.
  • the patient history database may comprise an SD memory card interface and one or more prescriptions may be stored on a portable SD memory card.
  • the patient history database may be configured to receive and/or transmit data from to any suitable device/module/database, including, but not limited to, modules residing in the physician control device, a vestibular stimulation device, a patient control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • modules residing in the physician control device including, but not limited to, modules residing in the physician control device, a vestibular stimulation device, a patient control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • the patient history database may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • Patient information may comprise any suitable information that is associated with a patient, including, but not limited to, the patient's medical history, the patient's current symptoms (if any),the patient's present diagnosis (if any), the patient's current prescriptions (if any) and data associated with the delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of the patient.
  • the physician control device may comprise any I O device drivers, including, but not limited to, software routines accessed through the operating system by the applications to communicate with devices such as I/O ports, memory components, vestibular stimulation devices, patient control devices and/or physician support devices.
  • the physician control device may be configured (e.g., with computer instructions (i.e., software)) to operate in a plurality of distinct modes. In each mode, the physician control device may be configured to permit access to some functionalities/modules and to prevent access to other functionalities/modules.
  • the physician control device may be configured to operate in a physician mode, wherein the user is allowed to perform physician-oriented tasks, such as generating, modifying, updating and/or extending a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient, but is prevented from accessing other functionalities/modules (e.g., the user may be prevented from generating and/or modifying one or more thermal waveforms).
  • physician control device may be configured to operate in a researcher mode, wherein the user is allowed to perform researcher-oriented tasks, such as generating and/or modifying one or more idealized thermal waveforms, but is prevented from accessing other functionalities/modules (e.g.
  • the user may be prevented from modifying the underlying operational parameters of the physician control device).
  • the physician control device may be configured to operate in an engineer mode, wherein the user is allowed to access all of the physician control device's functionalities/modules.
  • Each mode may be protected via a unique security measure (e.g. , the physician control device may be configured such that each mode is protected by a unique password).
  • the physician control device 2 comprises memory 20, a processor 21 and a power supply 22 (e.g., an internal power supply), wherein memory 20 is representative of the overall hierarchy of memory devices containing software and data used to implement the functionality of the physician control device 2 and wherein the processor 21 communicates with the memory 20 via an address/data bus 200.
  • a power supply 22 e.g., an internal power supply
  • memory 20 comprises an operating system 20a, applications 20b (e.g., a waveform module 2a configured to generate and/or modify the parameters, indications and/or approvals of one or more thermal waveforms; a treatment module 2b configured to generate, modify, update and/or extend a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient; a network module 2d configured to receive and/or transmit data, a GUI module 2e configured to display information and/or accept user input and/or a feedback module 2f configured to receive, transmit, and/or analyze data), data 20c (e.g., a waveform database 2h comprising data associated with the parameters, indications and/or approvals of one or more thermal waveforms; a prescription database 2i comprising at least one prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient; a feedback database 2j comprising a wave
  • data 20c comprises one or more databases stored on a portable memory device.
  • data 20c may comprise an SD memory card interface and a portable SD memory card comprising a waveform database 2h, a prescription database 2i, a feedback database 2j and/or a patient history database 2k.
  • the network module 2d is configured to receive data associated with the parameters, indications and/or approvals of one or more thermal waveforms from the waveform module 2a, a patient control device, a physician support device, a registry and/or a portable memory device (e.g., an SD memory card) and to transmit the data to the waveform database 2h for storage.
  • the data is stored on an SD memory card inserted into an SD memory card interface.
  • the network module 2d is configured to retrieve data associated with the parameters, indications and/or approvals of one or more thermal waveforms from the waveform database 2h, a physician support device, a registry and/or a portable memory device (e.g., an SD memory card) and to transmit the data to the waveform module 2a, the treatment module 2b, a vestibular stimulation device, a patient control device and/or a physician support device.
  • the network module 2d is configured to receive one or more prescriptions from the treatment module 2b, a patient control device, a physician support device, a registry and/or a portable memory device (e.g., an SD memory card) and to transmit the prescription(s) to the prescription database 2i for storage.
  • the prescription(s) is/are stored on an SD memory card inserted into an SD memory card interface.
  • the network module 2d is configured to retrieve one or more prescriptions from the prescription database 2i, a physician support device, a registry and/or a portable memory device (e.g., an SD memory card) and to transmit the prescription(s) to the treatment module 2b, a vestibular stimulation device, a patient control device and/or a physician support device.
  • a physician support device e.g., a physician support device
  • a registry and/or a portable memory device e.g., an SD memory card
  • the network module 2d is configured to receive controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data and/or physician feedback data from a vestibular stimulation device, a patient control device and/or a portable memory device (e.g., an SD memory card) and to transmit that data to the feedback database 2j for storage.
  • the data is stored on an SD memory card inserted into an SD memory card interface.
  • the network module 2d is configured to receive physician feedback data from the GUI module 2e and to transmit that data to the feedback database 2j for storage.
  • the patient information is stored on an SD memory card inserted into an SD memory card interface.
  • the network module 2d is configured to retrieve controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces and/or physician feedback data from the feedback database 2j and to transmit the data to the feedback module 2f, a physician support device, a registry and/or a portable memory device (e.g. , an SD memory card).
  • the network module 2d is configured to receive patient information from the GUI module 2e, a vestibular stimulation device, a patient control device, a physician support device, a registry and/or a portable memory device (e.g., an SD memory card) and to transmit that data to the patient history database 2k for storage.
  • the patient information is stored on an SD memory card inserted into an SD memory card interface.
  • the network module 2d is configured to retrieve patient information from the patient history database 2k and to transmit the patient information to a physician support device, a registry and/or a portable memory device (e.g., an SD memory card).
  • a physician support device e.g., a physician support device
  • a registry e.g., an SD memory card.
  • a portable memory device e.g., an SD memory card.
  • the present invention provides a patient control device for receiving, analyzing and/or transmitting data.
  • the patient control device is configured to receive a prescription comprising instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient from a physician control device and to transmit the prescription to a vestibular stimulation device (e.g., a vestibular stimulation device of the present invention).
  • a vestibular stimulation device e.g., a vestibular stimulation device of the present invention.
  • the patient control device comprises, consists essentially of or consists of a network module, a feedback module, a prescription database and a feedback database.
  • the network module is configured to receive one or more prescriptions from a physician control device, to transmit the prescription(s) to a vestibular stimulation device, to receive feedback data from the vestibular stimulation device and to transmit the feedback data to the physician control device.
  • the prescription database comprises one or more prescriptions (e.g., one or more prescriptions received from a physician control device), and the feedback database comprises data associated with the delivery of one or more thermal waveforms, data associated with the fit or one or more earpieces and/or patient feedback data.
  • a patient control device of the present invention may be any suitable computing device/system, including, but not limited to, a desktop computer, a laptop computer, a handheld computer, a personal digital assistant (PDA), and a smart phone.
  • a desktop computer including, but not limited to, a desktop computer, a laptop computer, a handheld computer, a personal digital assistant (PDA), and a smart phone.
  • PDA personal digital assistant
  • any conventional security means may be provided to prevent unauthorized activation of the patient control device.
  • the patient control device may be password protected.
  • the patient control support device may be configured to receive and/or transmit and suitable data, including, but not limited to, data associated with the parameters, indications and/or approvals of one or more thermal waveforms, data associated with one or more prescriptions, controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data and/or patient information.
  • the patient control device may be configured to receive and/or transmit data from/to various devices, including, but not limited to, a vestibular stimulation device, a physician control device, a physician support device, a TED, a sensor and/or a portable memory device (e.g., an SD memory card).
  • various devices including, but not limited to, a vestibular stimulation device, a physician control device, a physician support device, a TED, a sensor and/or a portable memory device (e.g., an SD memory card).
  • the patient control device is configured to receive data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g., idealized thermal waveforms) from a physician control device, a physician support device, a registry and/or a portable memory device (e.g., an SD memory card); to transmit data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g., idealized thermal waveforms) to a vestibular stimulation device and/or a portable memory device (e.g., an SD memory card); to receive one or more prescriptions from a physician control device, a physician support device, a registry and/or a portable memory device (e.g., an SD memory card); to transmit one or more prescriptions to a vestibular stimulation device and/or a portable memory device (e.g., an SD memory card); to receive one or more prescription modifications, updates and/or extensions from a physician control device, a physician support device, a registry and/or a
  • an SD memory card to receive data associated with the delivery of one or more thermal waveforms (e.g., idealized thermal waveforms) from a vestibular stimulation device and/or a portable memory device (e.g. , an SD memory card); to transmit data associated with the delivery of one or more thermal waveforms (e.g., idealized thermal waveforms) to a physician control device, a physician support device, a registry and/or a portable memory device (e.g., an SD memory card); to transmit patient feedback data to a physician control device, a physician support device, a registry and/or a portable memory device (e.g., an SD memory card); to receive patient information from a vestibular stimulation device and/or a portable memory device (e.g., an SD memory card) and/or to transmit patient information to a physician control device, a physician support device, a registry and/or a portable memory device (e.g., an SD memory card).
  • a physician control device e.g., idealized thermal waveform
  • the patient control device may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the patient control device comprises memory, a processor and a power supply.
  • the processor may be any commercially available or custom microprocessor.
  • Memory can include, but is not limited to, the following types of devices: cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.
  • the power supply may be an internal power supply (e.g., one or more rechargeable batteries that may be recharged without first being removed from the physician control device).
  • the patient control device 's memory may comprise any suitable software and/or data, including, but not limited to, an operating system, applications, data and input/output (I/O) drivers.
  • the patient control device may use any suitable operating system, including, but not limited to, OS/2, AIX, OS/390 or System390 from International Business Machines Corp. (Armonk, NY), Window CE, Windows NT, Windows95, Windows98, Windows2000, Windows 7 or Windows Vista from Microsoft Corp. (Redmond, WA), Mac OS from Apple, Inc. (Cupertino, CA), Unix, Linux or Android.
  • the patient control device may comprise any suitable application, including, but not limited to, one or more programs configured to implement one or more of the various features of the present invention.
  • the patient control device may comprise a network module configured to receive and/or transmit data; a GUI module configured to display information and/or accept user input; a feedback module configured to receive, transmit, and/or analyze data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data and/or patient information; an alert generation module configured to generate one or more alert messages; a tone generation module configured to produce one or more audible tones; a visual indicator module configured to produce one or more visual indicators and/or a security module configured to prevent unauthorized use of the patient control device.
  • two or more of the aforementioned modules are combined to form a single module configured to carry out the function(s) of each of the individual modules (e.g., the patient control device may comprise a network- feedback module that receives feedback data from a vestibular stimulation device, analyzes the data and transmits the data and the results of its analysis to a physician control device ).
  • the patient control device may comprise a delivery feedback module that receives data associated with the delivery of one or more thermal waveforms from a vestibular stimulation device and a patient feedback module that receives patient feedback data from the a GUI module residing in the patient control device).
  • one or more of the functions described below with respect to one of the modules described below is performed by one of the other modules described below (e.g., the network module, rather than the feedback module may be configured to receive feedback data from a vestibular stimulation device, while the feedback module is tasked only with analyzing the data).
  • the network module rather than the feedback module may be configured to receive feedback data from a vestibular stimulation device, while the feedback module is tasked only with analyzing the data.
  • the patient control device comprises a network module configured to receive, retrieve and/or transmit data.
  • the network module may be configured to receive, retrieve and/or transmit data from/to any suitable device/module/database, including, but not limited to, other modules residing in the patient control device, databases residing in the patient control device, a vestibular stimulation device, a physician control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • a suitable device/module/database including, but not limited to, other modules residing in the patient control device, databases residing in the patient control device, a vestibular stimulation device, a physician control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • the network module may be configured to receive, retrieve and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the network module may be configured to receive, retrieve and/or transmit any suitable data, including, but not limited to, data associated with the parameters, indications and/or approvals of one or more thermal waveforms, one or more prescriptions, controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data and/or patient information.
  • the network module is configured to receive and/or retrieve data associated with the parameters, indications and/or approvals of one or more thermal waveforms from a waveform database residing in the patient control device, from a vestibular stimulation device, from a physician control device, from a physician support device, from a registry and/or from a portable memory device.
  • the network module is configured to receive and/or retrieve one or more prescriptions from a prescription database residing in the patient control device, from a vestibular stimulation device, from a physician control device, from a physician support device, from a registry and/or from a portable memory device.
  • the network module is configured to receive and/or retrieve controller feedback data, data associated with the delivery of one or more thermal waveforms and/or data associated with the fit of one or more earpieces from a feedback module/database residing in the patient control device and/or a vestibular stimulation device.
  • the network module is configured to receive and/or retrieve patient feedback data and/or patient information from a feedback module/database residing in the patient control device, from a GUI module residing in the patient control device, from a patient information database residing in the patient control device, from a vestibular stimulation device, from a physician control device, from a physician support device, from a registry and/or from a portable memory device.
  • the network module is configured to transmit data associated with the parameters, indications and/or approvals of one or more thermal waveforms to a waveform database residing in the patient control device, to a vestibular stimulation device, to a physician control device, to a physician support device, to a registry and/or to a portable memory device.
  • the network module is configured to transmit one or more prescriptions to a prescription database residing in the patient control device, to a vestibular stimulation device, to a physician control device, to a physician support device, to a registry and/or to a portable memory device.
  • the network module is configured to transmit controller feedback data, data associated with the delivery of one or more thermal waveforms and/or data associated with the fit of one or more earpieces to a feedback module/database residing in the patient control device, to a vestibular stimulation device, to a physician control device, to a physician support device, to a registry and/or to a portable memory device.
  • the network module is configured to transmit patient feedback data and/or patient information to a feedback module/database residing in the patient control device, to a patient information database residing in the patient control device, to a vestibular stimulation device, to a physician control device, to a physician support device, to a registry and/or to a portable memory device.
  • the network module is configured to access a database comprising data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g., idealized thermal waveforms).
  • the network module maybe configured to access a waveform database residing in a vestibular stimulation device, a waveform database residing in the patient control device, a waveform database residing in a physician control device, a waveform database residing in a physician support device, a waveform database residing in a registry and/or a waveform database residing in a portable memory device.
  • the network module is configured to access a database comprising one or more prescriptions.
  • the network module maybe configured to access a prescription database residing in a vestibular stimulation device, a prescription database residing in the patient control device, a prescription database residing in a physician control device, a prescription database residing in a physician support device, a prescription database residing in a registry and/or a prescription database residing in a portable memory device.
  • the network module is configured to access a database comprising controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data and/or physician feedback data.
  • the network module maybe configured to access a feedback database residing in a vestibular stimulation device, a feedback database residing in the patient control device, a feedback database residing in a physician control device, a feedback database residing in a physician support device, a feedback database residing in a registry and/or a feedback database residing in a portable memory device.
  • the network module is configured to access a database comprising patient information.
  • the network module maybe configured to access a patient information database residing in a vestibular stimulation device, a patient information database residing in the patient control device, a patient information database residing in a physician control device, a patient information database residing in a physician support device, a patient information database residing in a registry and/or a patient information database residing in a portable memory device.
  • the patient control device comprises a GUI module configured to display information and/or to accept user input.
  • GUI Any suitable GUI may be used, including, but not limited to, a keyboard, a mouse, an LCD display with one or more associated entry keys and an interactive touch screen.
  • the GUI may comprise a static pressure touch-sensitive display, a capacitive touch-sensitive display, a resistive touch- sensitive display, an electrostatic capacity proximity sensor, a magnetic proximity sensor and /or an infrared proximity sensor. See, e.g. , U.S. Patent Publication Nos. 2011/0271222, 2011/0273575, 2011/0275414 and 2011/0275416.
  • the GUI module may be configured to display any suitable information, including, but not limited to, data associated with the delivery of one or more thermal waveforms.
  • the GUI module may be configured to display the current date and/or time (as discussed above with respect to Figure 10); delivery of one or morethe current temperature(s) of the earpiece(s) associated with the controller; the current temperature(s) of a patient's ear canal(s); the current temperature(s) of a patient's inner ear(s); the current temperature(s) of the heat Sindelivery of one or morethe current temperature(s) of the earpiece(s) associated with the controller; the current temperature(s) of a patient's ear canal(s); the current temperature(s) of a patient's inner ear(s); the current temperature(s) of the heat sine controller; one or more target temperatures (as discussed above with respect to Figure 11); the amount of time that has elapsed since the onset of delivery of one or more thermal waveforms (as discussed above with respect to Figure
  • a patient-reported pain score e.g. , blood Ale levels, blood glucose levels and blood Cortisol levels
  • saliva chemistry data e.g., saliva Cortisol levels
  • urine chemistry data e.g., urine Cortisol levels
  • comments a patient made about his/her treatment session(s) e.g., comments made to a physician, submitted in response to an automated survey and/or recorded in a treatment diary
  • the impedance between an earpiece inserted into the ear canal of a patient and an electrode affixed to a second location on/in said patient's body e.g., an electrode placed in or adjacent to the patient's other ear canal
  • the rate at which a patient's inner ear cools in response to a cooling stimulus e.g., data from a temperature sensor, such as thermistor, that monitors how quickly the inner ear cools in response to a cooling waveform
  • the GUI module may be configured to accept any suitable user input, including, but not limited to, patient feedback data and/or patient information.
  • the GUI module may be configured to accept a pain score and/or patient comments regarding the effectiveness of a treatment session.
  • the GUI module is configured to allow a user to initiate/stop a treatment session (e.g., by pushing/selecting an emergency shutoff button/icon) (as discussed above with respect to Figure 11).
  • the patient control device comprises a feedback module configured to receive, transmit and/or analyze data.
  • the feedback module may be configured to receive and/or transmit data from/to any suitable device/module/database, including, but not limited to, other modules residing in the patient control device, databases residing in the patient control device, a vestibular stimulation device, a physician control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g. , an SD memory card).
  • a suitable device/module/database including, but not limited to, other modules residing in the patient control device, databases residing in the patient control device, a vestibular stimulation device, a physician control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g. , an SD memory card).
  • the feedback module may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the feedback module may be configured to receive, transmit and/or analyze any suitable data, including, but not limited to, controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data and/or patient information.
  • the feedback module is configured to receive and/or analyze data associated with the delivery of one or more thermal waveforms and/or data associated with the fit of one or more earpieces from a feedback database residing in the physician control device, from one or more vestibular stimulation devices.
  • the feedback module may be configured to analyze the accuracy with which one or more prescribed waveforms was delivered to a patient, the fit of an earpiece based upon the rate at which the temperature of the earpiece changes in response to a cooling/warming waveform, the slew rate associated with one or more TEDs, the impedance between an earpiece positioned in the left ear canal of a patient and an earpiece positioned in the right ear canal of a patient, the impedance between an earpiece positioned in the ear canal of a patient and an electrode affixed to a second location on in the patient's body, etc.
  • the feedback module is configured to receive and/or analyze patient feedback data and/or patient information from a GUI module residing in the patient control device, from a feedback database residing in the patient control device, from a patient information database residing in the patient, from a vestibular stimulation device, from a physician control device, from a physician support device and/or from a portable memory device.
  • the feedback module may be configured to analyze the effectiveness of a given thermal waveform or combination of thermal waveforms (e.g., by analyzing pain scores entered before, during and after a treatment session), the effect(s) of one or more waveform modifications (e.g. , by analyzing whether/how much a given waveform modification changed the effectiveness of a thermal waveform in treating a disease/disorder), etc.
  • the feedback module is configured to transmit data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data, patient information and/or data associated with its analysis to a feedback database residing in the patient control device, to a patient information database residing in the patient control device, to a physician control device, to a physician support device, to a registry and/or to a portable memory device (e.g., an SD memory card).
  • a portable memory device e.g., an SD memory card
  • the patient control device comprises an alert generation module configured to generate one or more alert messages.
  • the alert generation module may be configured to generate any suitable alert message, including, but not limited to, a reminder that a patient is due for a treatment session; a reminder that a patient must enter patient feedback data (e.g. , a pain score) following a treatment session; an indication of the number of treatment sessions remaining in a prescription; an error message indicating that a treatment session has been interrupted due to a system error; a reminder that a patient must contact his/her physician to update/extend his/her prescription; a warning that the patient control device's internal power supply is low and a warning that the internal power supply of an associated vestibular stimulation device is low.
  • patient feedback data e.g. , a pain score
  • the alert generation module is configured to communicate with various devices/modules, including, but not limited to, a vestibular stimulation device, a physician control device, a physician support device, a TED, a sensor, a portable memory device (e.g., an SD memory card) and other modules of the patient control device.
  • the alert generation module may be configured to provide instructions to the GUI module and/or the tone generation module for displaying one or more alert messages and/or for generation an audible tone to alert a user of the presence of the one or more alert messages.
  • the graphical user interface module may be configured to display the one or more alert messages immediately upon generation or upon interaction with a user (e.g., an alert notification icon may be generated, with the alert message being displayed only after the user indicates that he/she wishes to view the message).
  • an alert notification icon may be generated, with the alert message being displayed only after the user indicates that he/she wishes to view the message.
  • the patient control device comprises a tone generation module configured to produce audible tones.
  • the tone generation module comprises a piezo buzzer.
  • Audible tones may be produced to alert a user to various circumstances/events, including, but not limited to, the existence of an unread/unviewed alert message. Audible tones may be generated repeatedly in response to a single circumstance/event (e.g., an audible tone may be generated repeatedly until the user views/reads the message) and may become progressively louder and/or more frequent with time.
  • the patient control device comprises a visual indicator module configured to notify a user of the existence of an unread/unviewed alert message.
  • the visual indicator module comprises an LED indicator light.
  • the visual indicator module may be activated repeatedly in response to a single alert message (e.g. , an LED light may be illuminated repeatedly until the user views/reads the message) or may remain activated until the user views/reads the message.
  • the patient control device comprises a security module configured to prevent unauthorized use of the physician control device (i.e., to prevent unauthorized persons from using the patient control device, to prevent authorized persons from using the patient control device in an unauthorized manner, etc.).
  • the security module may be configured to prevent unauthorized use of the patient control device using any suitable means of security, including, but not limited to, password protection and data encryption.
  • the security module may be configured such that a user is required to input a designated password prior to entering/viewing patient feedback data; and/or entering/viewing patient information (as discussed above with respect to Figure 12).
  • the patient control device may comprise any suitable data, including, but not limited to, static and/or dynamic data used by the operating system, applications, I/O device drivers and other software components, controller feedback data, data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g., idealized thermal waveforms), data associated with one or more prescriptions, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data and patient information.
  • thermal waveforms e.g., idealized thermal waveforms
  • the patient control device may comprise a waveform database comprising data associated with one or more idealized thermal waveforms; a prescription database comprising data associated with one or more prescriptions; a feedback database comprising controller feedback data, data associated with the delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of a patient and patient feedback data and/or a patient history database comprising data associated with one or more patients.
  • a waveform database comprising data associated with one or more idealized thermal waveforms
  • a prescription database comprising data associated with one or more prescriptions
  • a feedback database comprising controller feedback data, data associated with the delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of a patient and patient feedback data and/or a patient history database comprising data associated with one or more patients.
  • a feedback database comprising controller feedback data, data associated with the delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of a patient and patient feedback data and/or a patient history
  • one of the aforementioned databases is split into two or more distinct databases (e.g., the patient control device may comprise a delivery feedback database comprising data associated with the specific parameters of the thermal waveform(s) delivered to a patient and a patient feedback database comprising patient feedback data).
  • the patient information database rather than the feedback database, may be configured to receive/store patient feedback data.
  • data is transmitted, received and/or stored in a controlled format (e.g., in a standardized format using forms/programs supplied by a physician support device or a registry).
  • the patient control device may be configured to transmit, receive and store data in a manner that ensures compliance with any and all applicable laws and/or regulations (e.g., the Health Insurance Portability and Accountability Act of 1996 (P.L. 104-191; " ⁇ ”)).
  • the patient control device comprises a waveform database configured to receive, store and/or transmit data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g, one or more idealized thermal waveforms).
  • the waveform database is configured such that one or more of the thermal waveforms stored therein is/are protected (e.g., users may be prevented from modifying and/or deleting the idealized thermal waveform(s) stored in the waveform database).
  • the waveform database may comprise any suitable type of memory including, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.
  • the waveform database comprises a portable memory device, such as an SD memory card or a USB memory stick.
  • the waveform database may comprise an SD memory card interface and one or more prescriptions may be stored on a portable SD memory card.
  • the waveform database may be configured to receive and/or transmit data from/to any suitable device/module/database, including, but not limited to, modules residing in the patient control device, a vestibular stimulation device, a physician control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • modules residing in the patient control device including, but not limited to, modules residing in the patient control device, a vestibular stimulation device, a physician control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • the waveform database may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the patient control device comprises a prescription database configured to receive, transmit and/or store one or more prescriptions, wherein each prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • the prescription database may comprise any suitable type of memory including, but not limited to, cache,
  • the prescription database comprises a portable memory device, such as an SD memory card or a USB memory stick.
  • the prescription database may comprise an SD memory card interface and one or more prescriptions may be stored on a portable SD memory card.
  • the prescription database may be configured to receive and/or transmit data from/to any suitable device/module/database, including, but not limited to, modules residing in the patient control device, a vestibular stimulation device, a physician control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • modules residing in the patient control device including, but not limited to, modules residing in the patient control device, a vestibular stimulation device, a physician control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • the prescription database may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the patient control device comprises a feedback database configured to receive, transmit and/or store feedback data.
  • the feedback database may comprise any suitable type of memory including, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.
  • the feedback database comprises a portable memory device, such as an SD memory card or a USB memory stick.
  • the feedback database may comprise an SD memory card interface and one or more prescriptions may be stored on a portable SD memory card.
  • the feedback database may be configured to receive and/or transmit feedback data from/to any suitable device/module/database, including, but not limited to, modules residing in the patient control device, a vestibular stimulation device, a physician control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • the feedback database may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • Feedback data may comprise any suitable data, including, but not limited to, controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data and/or patient information.
  • the feedback database may comprise a log file detailing the target time/temperature parameters of one or more prescribed thermal waveform(s); the time/temperature parameters of the thermal waveform(s) delivered to a patient; the date/time of delivery of the thermal waveform(s) delivered to a patient; the temperature(s) of a patient's ear canal(s) at various time points before, during and/or after delivery of one or more thermal waveforms; the temperature(s) of a patient's inner ear(s) at various time points before, during and/or after delivery of one or more thermal waveforms; the fit of one or more earpieces at various time points before, during and/or after delivery of one or more thermal waveforms; an estimate of the thermal contact between one or more earpieces and a patient's
  • data from a temperature sensor such as thermistor, that monitors how quickly the earpiece cools in response to a cooling waveform
  • the rate at which an earpiece is warmed in response to a warming stimulus e.g., data from a temperature sensor, such as a thermistor, that monitors how quickly the earpiece warms in response to a warming waveform
  • the rate at which a patient's ear canal and/or inner ear cooled in response to a cooling stimulus e.g., data from a temperature sensor, such as thermistor, that monitors how quickly the ear canal and/or the inner ear cools in response to a cooling waveform
  • the rate at which a patient's ear canal and/or inner ear warmed in response to a warming stimulus e.g., data from a temperature sensor, such as a thermistor, that monitors how quickly the ear canal and/or the inner ear warms in response to a warming waveform
  • the patient control device comprises a patient history database configured to receive, transmit and/or store patient information.
  • the patient history database may comprise any suitable type of memory including, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.
  • the patient history database comprises a portable memory device, such as an SD memory card or a USB memory stick.
  • the patient history database may comprise an SD memory card interface and one or more prescriptions may be stored on a portable SD memory card.
  • the patient history database may be configured to receive and/or transmit data from/to any suitable device/module/database, including, but not limited to, modules residing in the patient control device, a vestibular stimulation device, a physician control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g. , an SD memory card).
  • modules residing in the patient control device including, but not limited to, modules residing in the patient control device, a vestibular stimulation device, a physician control device, a physician support device, a registry, a TED, a sensor and a portable memory device (e.g. , an SD memory card).
  • the patient history database may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • Patient information may comprise any suitable information that is associated with a patient, including, but not limited to, the patient's medical history, the patient's current symptoms (if any),the patient's present diagnosis (if any), the patient's current prescriptions (if any) and data associated with the delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of the patient.
  • the patient control device may comprise any I O device drivers, including, but not limited to, software routines accessed through the operating system by the applications to communicate with devices such as I/O ports, memory components, vestibular stimulation devices, physician control devices and/or physician support devices.
  • the patient control device may be configured (e.g. , with computer instructions (i.e., software)) to operate in a plurality of distinct modes. In each mode, the patient control device may be configured to permit access to some functionalities/modules and to prevent access to other functionalities/modules.
  • the patient control device may be configured to operate in a patient mode, wherein the user is allowed to perform patient-oriented tasks, such as starting/stopping a treatment session and/or providing feedback regarding the effectiveness of a treatment session, but is prevented from accessing other modules/databases/functionalities (e.g. , the user may be prevented generating, modifying, updating and/or extending prescriptions).
  • the patient control device may be configured to operate in an engineer mode, wherein the user is allowed to access all of the patient control device's functionalities/modules.
  • Each mode may be protected via a unique security measure (e.g., the patient control device may be configured such that each mode is protected by a unique password).
  • the patient control device 3 comprises memory 30, a processor 31 and a power supply 32 (e.g., an internal power supply), wherein memory 30 is representative of the overall hierarchy of memory devices containing software and data used to implement the functionality of the patient control device 3 and wherein the processor 31 communicates with the memory 30 via an address/data bus 300.
  • memory 30 comprises an operating system 30a, applications 30b (e.g., a network module 3d configured to receive and/or transmit data, a GUI module 3e configured to display information and/or accept user input and/or a feedback module 3f configured to receive, transmit, and/or analyze data associated with the delivery of one or more thermal waveforms), data 30c ⁇ e.g.
  • a waveform database 3h comprising data associated with the parameters, indications and/or approvals of one or more thermal waveforms
  • a prescription database 3i comprising at least one prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient
  • a feedback database 3j comprising data associated with the delivery of one or more thermal waveforms and/or a patient history database 3k comprising patient information
  • I/O drivers 30d comprises one or more databases stored on a portable memory device.
  • data 30c may comprise an SD memory card interface and a portable SD memory card comprising a waveform database 3h, a prescription database 3i, a feedback database 3j and/or a patient history database 3k.
  • the network module 3d is configured to receive data associated with the parameters, indications and/or approvals of one or more thermal waveforms from a physician control device, a physician support device, a registry and/or a portable memory device (e.g., an SD memory card) and to transmit the data to the waveform database 3h for storage.
  • a physician control device e.g., a physician control device
  • physician support device e.g., a physician support device
  • a registry and/or a portable memory device e.g., an SD memory card
  • the data is stored on an SD memory card inserted into an SD memory card interface.
  • the network module 3d is configured to retrieve data associated with the parameters, indications and/or approvals of one or more thermal waveforms from the waveform database 3h, a physician control device, a physician support device, a registry and/or a portable memory device ⁇ e.g., an SD memory card) and to transmit the data to a vestibular stimulation device.
  • the network module 3d is configured to receive one or more prescriptions from a physician control device, a physician support device, a registry and/or a portable memory device ⁇ e.g., an SD memory card) and to transmit the prescription(s) to the prescription database 3i for storage.
  • the prescription(s) is/are stored on an SD memory card inserted into an SD memory card interface.
  • the network module 3d is configured to retrieve one or more prescriptions from the prescription database 3i, a physician control device, a physician support device, a registry and/or a portable memory device ⁇ e.g., an SD memory card) and to transmit the prescription(s) to a vestibular stimulation device.
  • the network module 3d is configured to receive controller feedback data, data associated with the delivery of one or more thermal waveforms and/or data associated with the fit of one or more earpieces from a vestibular stimulation device and/or a portable memory device ⁇ e.g. , an SD memory card) and to transmit that data to the feedback database 3j for storage.
  • the data is stored on an SD memory card inserted into an SD memory card interface.
  • the network module 3d is configured to retrieve controller feedback data, data associated with the delivery of one or more thermal waveforms and/or data associated with the fit of one or more earpieces from the feedback database 3j and to transmit the data to the feedback module 3f, a physician control device, a physician support device, a registry and/or a portable memory device ⁇ e.g., an SD memory card).
  • the network module 3d is configured to receive patient feedback data from the GUI module 3e, a vestibular stimulation device and/or a portable memory device ⁇ e.g., an SD memory card) and to transmit that data to the feedback database 3j for storage.
  • the patient information is stored on an SD memory card inserted into an SD memory card interface.
  • the network module 3d is configured to retrieve patient feedback data from the feedback database 3j and to transmit the data to the feedback module 3f, a physician control device, a physician support device, a registry and/or a portable memory device ⁇ e.g., an SD memory card).
  • the network module 3d is configured to receive patient information from the GUI module 3e, a vestibular stimulation device, a physician control device, a physician support device, a registry and/or a portable memory device (e.g. , an SD memory card) and to transmit that data to the patient history database 3k for storage.
  • the patient information is stored on an SD memory card inserted into an SD memory card interface.
  • the network module 3d is configured to retrieve patient information from the patient history database 3k and to transmit the patient information to a physician control device, a physician support device, a registry and/or a portable memory device (e.g., an SD memory card).
  • Physician Support Device e.g., an SD memory card.
  • the present invention provides a physician support device for generating and/or modifying the parameters, indications and/or approvals of one of more thermal waveforms; for generating, modifying, updating and/or extending one or more prescriptions and/or for receiving, analyzing and/or transmitting data.
  • the physician support device is configured to generate and/or modify the parameters, indications and/or approvals of one or more idealized thermal waveforms and to transmit the parameters, indications and/or approvals of the idealized thermal waveform(s) to a physician control device (e.g., a physician control device of the present invention).
  • a physician control device e.g., a physician control device of the present invention
  • the physician support device comprises, consists essentially of or consists of a waveform module configured to generate and/or modify the parameters, indications and/or approvals of one or more idealized thermal waveforms and a network module configured to transmit the parameters, indications and/or approvals of the idealized thermal waveform(s) to one or more physician control devices.
  • a physician support device of the present invention may be any suitable computing device/system, including, but not limited to, a desktop computer, a laptop computer, a handheld computer, a personal digital assistant (PDA), and a smart phone.
  • a desktop computer including, but not limited to, a desktop computer, a laptop computer, a handheld computer, a personal digital assistant (PDA), and a smart phone.
  • PDA personal digital assistant
  • physician support device Any conventional security means may be provided to prevent unauthorized activation of the physician support device.
  • physician support device may be password protected.
  • the physician support device may be configured to receive and/or transmit and suitable data, including, but not limited to, data associated with the parameters, indications and/or approvals of one or more thermal waveforms, one or more prescriptions, controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and patient information.
  • the physician support device may be configured to receive and/or transmit data from/to various devices, including, but not limited to, a vestibular stimulation device, a patient control device, a physician control device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • the physician support device is configured to receive data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g.
  • idealized thermal waveforms from a registry and/or a portable memory device (e.g., an SD memory card); to transmit data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g., idealized thermal waveforms) to a vestibular stimulation device, a patient control device, a physician control device, a registry and/or a portable memory device (e.g., an SD memory card); to receive one or more prescriptions from a registry and/or a portable memory device (e.g., an SD memory card); to transmit one or more prescriptions to a vestibular stimulation device, a patient control device, a physician control device, a registry and/or a portable memory device (e.g., an SD memory card); to transmit one or more prescription modifications, updates and/or extensions to a vestibular stimulation device, a patient control device, a physician control device, a registry and/or a portable memory device (e.g., an SD memory card); to receive data associated with the delivery of
  • a portable memory device e.g., an SD memory card
  • a vestibular stimulation device e.g., a vestibular stimulation device
  • a patient control device e.g., a physician control device
  • a registry e.g., an SD memory card
  • the physician support device may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the physician support device comprises memory, a processor and a power supply.
  • the processor may be any commercially available or custom microprocessor.
  • Memory can include, but is not limited to, the following types of devices: cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.
  • the power supply may be an internal power supply (e.g., one or more rechargeable batteries that may be recharged without first being removed from the physician control device).
  • the physician support device 's memory may comprise any suitable software and/or data, including, but not limited to, an operating system, applications, data and input/output (I/O) drivers.
  • the physician support device may use any suitable operating system, including, but not limited to, OS/2, ⁇ , OS/390 or System390 from International Business Machines Corp. (Armonk, NY), Window CE, Windows NT, Windows95, Windows98, Windows2000, Windows 7 or Windows Vista from Microsoft Corp. (Redmond, WA), Mac OS from Apple, Inc. (Cupertino, CA), Unix, Linux or Android.
  • OS/2 International Business Machines Corp.
  • ⁇ OS/390 or System390 from International Business Machines Corp. (Armonk, NY)
  • Window CE Windows NT, Windows95, Windows98, Windows2000, Windows 7 or Windows Vista from Microsoft Corp. (Redmond, WA), Mac OS from Apple, Inc. (Cupertino, CA), Unix, Linux or Android.
  • the physician support device may comprise any suitable application, including, but not limited to, one or more programs configured to implement one or more of the various features of the present invention.
  • the physician control device may comprise a waveform module that enables a user to generate and/or modify the parameters, indications and/or approvals of one or more thermal waveforms; a treatment module that enables a user to generate, modify, update and/or extend a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient; a network module configured to receive and/or transmit data; a GUI module configured to display information and/or accept user input; a feedback module configured to receive, transmit, and/or analyze data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and/or patient information; an alert generation module configured to generate one or more alert messages; a tone generation module configured to produce one
  • two or more of the aforementioned modules are combined to form a single module configured to carry out the function(s) of each of the individual modules (e.g., the physician support device may comprise a waveform-treatment module that enables a user to generate and/or modify one or more thermal waveforms and to generate, modify, update and/or extend a prescription).
  • the physician support device may comprise a waveform generation module that enables a user to generate the parameters, indications and/or approvals of one or more thermal waveforms and a waveform update module that enables a user to modify the parameters, indications and/or approvals of one or more thermal waveforms).
  • one or more of the functions described below with respect to one of the modules described below is performed by one of the other modules described below (e.g., the treatment module, rather than the waveform module, may be configured to modify the parameters, indications and/or approvals of one or more thermal waveforms).
  • the physician support device comprises a waveform module whereby a user may generate and/or modify the parameters, indications and/or approvals of one or more thermal waveforms.
  • the waveform module comprises software that enables a user to generate and/or modify the parameters of one or more thermal waveforms by point-to-point design and/or by utilizing mathematical functions.
  • the waveform module may comprise software that enables a user to generate and/or modify the parameters of a thermal waveform by selecting/altering one or more parameters, including, but not limited to, shape, frequency, amplitude and duration.
  • the waveform module enables a user to retrieve/select a thermal waveform from a database and then modify the parameters of that thermal waveform to generate a new thermal waveform.
  • the waveform module comprises software that enables a user to generate and/or modify the parameters, indications and/or approvals of one or more thermal waveforms using an interactive touch screen.
  • the waveform module may comprise software that enables a user to generate the parameters of a thermal waveform by drawing the desired waveform on an interactive touch screen (as discussed above with respect to Figure 3).
  • the waveform module may enable a user to modify the parameters of a thermal waveform by highlighting one or more points on the waveform and moving the point(s) to a new location (e.g. , a higher/lower temperature) (as discussed above with respect to Figure 4).
  • the waveform module comprises software that automatically adjusts the parameters of the thermal waveform(s) created by a user to account for system limitations.
  • the waveform module may comprise software that automatically adjusts the slope of a thermal waveform in accordance with the minimum/maximum temperature and/or the rate of temperature change that is achievable using a particular combination of earpiece(s), TED(s), etc. That is, the waveform module may comprise software that prevents a user from generating parameters for a thermal waveform that cannot be delivered because of system limitations.
  • the waveform module comprises software that enables a user to protect one or more thermal waveforms (i.e., to prevent one or more users from modifying the parameters, indications and/or approvals of the thermal waveform(s) and/or from deleting the thermal waveform(s) from a waveform database).
  • the waveform module may comprise software that enables a user to protect one or more idealized thermal waveforms (e.g., by requiring users to enter a specified password prior to modifying and/or deleting the idealized thermal waveform(s)).
  • the waveform module comprises software that enables a user to remove the protected status from one or more thermal waveforms.
  • the waveform module may comprise software that enables a user to remove the protected status from one or more idealized thermal waveforms (e.g., by entering the appropriate password).
  • the waveform module is configured to automatically generate and/or modify the parameters, indications and/or approvals of one or more thermal waveforms (e.g., idealized thermal waveforms) in response to data received from one or more devices/modules.
  • the waveform module may be configured to automatically update one or more thermal waveforms responsive to data received from one or more TEDs and/or one or more sensors.
  • the waveform module may be configured to retrieve the parameters, indications and/or approvals of one or more thermal waveforms from any suitable database, including, but not limited to, a waveform database residing in a vestibular stimulation device, a waveform database residing in a patient control device, a waveform database residing in a physician control device, a waveform database residing in the physician support device, a waveform database residing in a registry and/or a waveform database residing in a portable memory device (e.g., an SD memory card).
  • a portable memory device e.g., an SD memory card
  • Waveform parameters, indications and/or approvals generated and/or modified by the waveform module may be stored in a database.
  • the generated/modified parameters, indications and/or approvals are stored in a waveform database comprising data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g., idealized thermal waveforms).
  • the generated/modified waveform parameters, indications and/or approvals may be stored in a waveform database residing in a vestibular stimulation device, a waveform database residing in a patient control device, a waveform database residing in a physician control device, a waveform database residing in the physician support device, a waveform database residing in a registry and/or a waveform database residing in a portable memory device (e.g., an SD memory card).
  • a portable memory device e.g., an SD memory card
  • the physician support device comprises a treatment module whereby a user (e.g., a physician) may generate, modify, update and/or extend a prescription.
  • a user e.g., a physician
  • the treatment module may enable a user to generate, modify, update and/or extend a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • the treatment module comprises software that enables a user to select one or more thermal waveforms from a database (e.g. , an idealized thermal waveform from an idealized waveform database) and to provide instructions as to when/how each of those waveforms should be administered.
  • a database e.g. , an idealized thermal waveform from an idealized waveform database
  • a treatment module may comprise software that enables a user to provide instructions as to how long a treatment schedule is to last (as discussed above with respect to Figure 5), to provide instructions as to how many treatments may be administered each day (as discussed above with respect to Figure 5), to provide instructions as to how often each thermal waveform is to be administered (as discussed above with respect to Figure 6), to provide instructions as to what time(s) of day each thermal waveform is to be administered (as discussed above with respect to Figure 6 and 9), to select one or more idealized thermal waveforms from a database (as discussed above with respect to Figure 7), to provide instructions regarding whether each of the selected thermal waveforms is to be delivered to the right and/or left ear canal of a patient (as discussed above with respect to Figure 8), etc.
  • the treatment module comprises software that enables a user to modify, update and/or extend a prescription by changing one or more parameters of the prescription (as discussed above with respect to Figure 10), including, but not limited to, which thermal waveform(s) are delivered, frequency with which the thermal waveform(s) is/are delivered, and the expiration date of the prescription.
  • Any suitable prescription may be modified, updated and/or extended, including, but not limited to, prescriptions stored in a prescription database (e.g., a prescription database residing in a vestibular stimulation device, in a patient control device, in a physician control device, in the physician support device or in a portable memory device, such as a portable SD memory card).
  • the treatment module may be configured to retrieve/select thermal waveforms from any suitable database, including, but not limited to, a waveform database residing in a vestibular stimulation device, a waveform database residing in a patient control device, a waveform database residing in a physician control device, a waveform database residing in the physician support device, a waveform database residing in a registry and/or a waveform database residing in a portable memory device (e.g., an SD memory card).
  • a portable memory device e.g., an SD memory card
  • the treatment module may be configured to retrieve prescriptions from any suitable database, including, but not limited to, a prescription database residing in a vestibular stimulation device, a prescription database residing in a patient control device, a prescription database residing in a physician control device, a prescription database residing in the physician support device, a prescription database residing in a registry and/or a prescription database residing in a portable memory device (e.g., an SD memory card).
  • a prescription database residing in a vestibular stimulation device e.g., a prescription database residing in a patient control device
  • a prescription database residing in a physician control device e.g., a prescription database residing in the physician support device
  • a prescription database residing in a registry e.g., an SD memory card
  • Prescriptions generated, modified, updated and/or extended by the treatment module may be added to a database comprising one or more prescriptions.
  • the prescriptions may be stored in a prescription database residing in a vestibular stimulation device, a prescription database residing in a patient control device, a prescription database residing in a physician control device, a prescription database residing in the physician support device, a prescription database residing in a registry and/or a prescription database residing in a portable memory device.
  • the physician support device comprises a network module configured to receive, retrieve and/or transmit data.
  • the network module may be configured to receive, retrieve and/or transmit data from/to any suitable device/module/database, including, but not limited to, other modules residing in the physician support device, databases residing in the physician support device, a vestibular stimulation device, a patient control device, a physician control device, a registry, a TED, a sensor and a portable memory device (e.g. , an SD memory card).
  • a suitable device/module/database including, but not limited to, other modules residing in the physician support device, databases residing in the physician support device, a vestibular stimulation device, a patient control device, a physician control device, a registry, a TED, a sensor and a portable memory device (e.g. , an SD memory card).
  • the network module may be configured to receive, retrieve and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the network module may be configured to receive, retrieve and/or transmit any suitable data, including, but not limited to, data associated with the parameters, indications and/or approvals of one or more thermal waveforms, one or more prescriptions, controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and/or patient information.
  • data associated with the parameters, indications and/or approvals of one or more thermal waveforms, one or more prescriptions controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and/or patient information.
  • the network module is configured to receive and/or retrieve data associated with the parameters, indications and/or approvals of one or more thermal waveforms from a waveform module/database residing in the physician support device, from a vestibular stimulation device, from a patient control device, from a physician control device, from a registry and/or from a portable memory device.
  • the network module is configured to receive and/or retrieve one or more prescriptions from a treatment module residing in the physician support device, from a prescription database residing in the physician support device, from a vestibular stimulation device, from a patient control device, from a physician control device, from a registry and/or from a portable memory device.
  • the network module is configured to receive and/or retrieve controller feedback data, data associated with the delivery of one or more thermal waveforms and/or data associated with the fit of one or more earpieces from a feedback module/database residing in the physician support device, from a vestibular stimulation device and/or from a patient control device.
  • the network module is configured to receive and/or retrieve patient feedback data, physician feedback data and/or patient information from a feedback module/database residing in the physician support device, from a GUI module residing in the physician support device, from a patient information database residing in the physician support device, from a vestibular stimulation device, from a patient control device, from a physician control device, from a registry and/or from a portable memory device.
  • the network module is configured to transmit data associated with the parameters, indications and/or approvals of one or more thermal waveforms to a waveform module/database residing in the physician support device, to a treatment module residing in the physician support device, to a vestibular stimulation device, to a patient control device, to a physician control device, to a registry and/or to a portable memory device.
  • the network module is configured to transmit one or more prescriptions to a treatment module residing in the physician support device, to a prescription database residing in the physician support device, to a vestibular stimulation device, to a patient control device, to a physician control device, to a registry and/or to a portable memory device.
  • the network module is configured to transmit controller feedback data, data associated with the delivery of one or more thermal waveforms and/or data associated with the fit of one or more earpieces to a feedback module/database residing in the physician support device, to a vestibular stimulation device, to a patient control device, to a physician control device, to a registry and/or to a portable memory device.
  • the network module is configured to transmit patient feedback data, physician feedback data and/or patient information to a feedback module/database residing in the physician support device, to a patient information database residing in the physician support device, to a vestibular stimulation device, to a patient control device, to a physician control device, to a registry and/or to a portable memory device.
  • the network module is configured to access a database comprising data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g., idealized thermal waveforms).
  • the network module maybe configured to access a waveform database residing in a vestibular stimulation device, a waveform database residing in a patient control device, a waveform database residing in a physician control device, a waveform database residing in the physician support device, a waveform database residing in a registry and/or a waveform database residing in a portable memory device.
  • the network module is configured to access a database comprising one or more prescriptions.
  • the network module maybe configured to access a prescription database residing in a vestibular stimulation device, a prescription database residing in a patient control device, a prescription database residing in a physician control device, a prescription database residing in the physician support device, a prescription database residing in a registry and/or a prescription database residing in a portable memory device.
  • the network module is configured to access a database comprising controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data and/or physician feedback data.
  • the network module maybe configured to access a feedback database residing in a vestibular stimulation device, a feedback database residing in a patient control device, a feedback database residing in a physician control device, a feedback database residing in the physician support device, a feedback database residing in a registry and/or a feedback database residing in a portable memory device.
  • the network module is configured to access a database comprising patient information.
  • the network module maybe configured to access a patient information database residing in a vestibular stimulation device, a patient information database residing in a patient control device, a patient information database residing in a physician control device, a patient information database residing in the physician support device, a patient information database residing in a registry and/or a patient information database residing in a portable memory device.
  • the physician support device comprises a GUI module configured to display information and/or to accept user input.
  • GUI Any suitable GUI may be used, including, but not limited to, a keyboard, a mouse, an LCD display with one or more associated entry keys and an interactive touch screen.
  • the GUI may comprise a static pressure touch-sensitive display, a capacitive touch-sensitive display, a resistive touch- sensitive display, an electrostatic capacity proximity sensor, a magnetic proximity sensor and /or an infrared proximity sensor. See, e.g., U.S. Patent Publication Nos. 2011/0271222, 2011/0273575, 2011/0275414 and 2011/0275416.
  • the GUI module may be configured to display any suitable information, including, but not limited to, data associated with the delivery of one or more thermal waveforms.
  • the GUI module may be configured to display the current date and/or time (as discussed above with respect to Figure 10); one or more target temperatures (as discussed above with respect to Figure 11); the number of treatment sessions that have been administered for a prescription; the number of treatment sessions remaining in a prescription; the amount of time remaining until a prescription must be renewed/updated; the amount of remaining battery life, an alert message ⁇ e.g., a reminder to a physician that he/she needs to modify, update and/or extend a prescription); the target time/temperature parameters of one or more prescribed thermal waveform(s) (as discussed above with respect to Figure 11); the precise time/temperature parameters of the thermal waveform(s) delivered to a patient; the date/time of delivery of the thermal waveform(s) delivered to a patient; the temperature(s) of a patient's ear canal(s) at various time points before,
  • videos/images of a patient that may be used to assess mood
  • objectives measures of efficacy e.g., nystamography data, EEG data, M I data, heart rate data, blood pressure data
  • subjective measures of efficacy e.g., a patient-reported pain score
  • blood chemistry data e.g., blood Ale levels, blood glucose levels and blood Cortisol levels
  • saliva chemistry data e.g.
  • saliva Cortisol levels saliva Cortisol levels
  • urine chemistry data e.g., urine Cortisol levels
  • comments a patient made about his/her treatment session(s) e.g., comments made to a physician, submitted in response to an automated survey and/or recorded in a treatment diary
  • the impedance between an earpiece inserted into the ear canal of a patient and an electrode affixed to a second location on/in said patient's body e.g., an electrode placed in or adjacent to the patient's other ear canal
  • the rate at which a patient's inner ear cools in response to a cooling stimulus e.g., data from a temperature sensor, such as thermistor, that monitors how quickly the inner ear cools in response to a cooling waveform
  • the rate at which a patient's inner ear warms in response to a warming stimulus e.g.
  • a temperature sensor such as thermistor, that monitors how quickly the inner ear warms in response to a warming waveform
  • patient comments regarding the subjective fit of his/her earpiece(s)
  • physician comments regarding the effectiveness of one or more thermal waveforms and/or physician comments regarding the effect(s) of one or more waveform modifications.
  • the GUI module may be configured to accept any suitable user input, including, but not limited to, instructions for generating and/or modifying the parameters, indications and/or approvals of a thermal waveforms and/or instructions for generating, modifying, updating and/or extending a prescription.
  • the physician support device comprises a feedback module configured to receive, transmit and/or analyze data.
  • the feedback module may be configured to receive and/or transmit data from/to any suitable device/module/database, including, but not limited to, other modules residing in the physician support device, databases residing in the physician support device, a vestibular stimulation device, a patient control device, a physician control device, a registry, a TED, a sensor and a portable memory device (e.g. , an SD memory card).
  • a suitable device/module/database including, but not limited to, other modules residing in the physician support device, databases residing in the physician support device, a vestibular stimulation device, a patient control device, a physician control device, a registry, a TED, a sensor and a portable memory device (e.g. , an SD memory card).
  • the feedback module may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the feedback module may be configured to receive, transmit and/or analyze any suitable data, including, but not limited to, controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and/or patient information.
  • the feedback module is configured to receive and/or analyze controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and/or patient information from a GUI module residing in the physician support device, from a feedback database residing in the physician support device, from a patient information database residing in the physician support device, from a vestibular stimulation device, from a patient control device, from a physician control device and/or from a. portable memory device (e.g., an SD memory card).
  • the feedback module may be configured to analyze the accuracy with which one or more prescribed waveforms was delivered to a patient, the fit of an earpiece based upon the rate at which the temperature of the earpiece changes in response to a cooling/warming waveform, the slew rate associated with one or more TEDs, the impedance between an earpiece positioned in the left ear canal of a patient and an earpiece positioned in the right ear canal of a patient, the impedance between an earpiece positioned in the ear canal of a patient and an electrode affixed to a second location on/in the patient's body; the effectiveness of a given thermal waveform or combination of thermal waveforms (e.g., by analyzing pain scores entered before, during and after a treatment session); the effect(s) of one or more waveform modifications (e.g., by analyzing whether/how much a given waveform modification changed the effectiveness of a thermal waveform in treating a disease/disorder), etc.
  • the feedback module is configured to analyze data (e.g., patient feedback data, physician feedback data and/or patient information) to identify modifications that are likely to increase the effectiveness of a given thermal waveform, class of thermal waveforms or combination of thermal waveforms; to identify new diseases/disorders/injuries for which a given thermal waveform, class of thermal waveforms, combination of thermal waveforms and/or treatment regimen may provide an effective treatment; to predict which thermal waveform(s) or combination(s) of thermal waveforms may be most effective in treating a given disease/disorder/injury; to identify thermal waveforms, classes of thermal waveforms and/or combinations of thermal waveforms that are not likely to be effective in the treatment of a given disease/disorder/injury and/or to identify waveform characteristics that may be linked to increased/decreased efficacy with regard to the treatment of a given disease/disorder/injury.
  • data e.g., patient feedback data, physician feedback data and/or patient information
  • the feedback module may be configured to identify new idealized thermal waveforms by identifying one or more diseases/disorders/injuries for which a thermal waveform or class of waveforms is likely to be an effective treatment (e.g., by identifying a new thermal waveform that belongs to a class of waveforms known to be effective in treating one or more diseases/disorders/injuries).
  • the feedback module may be configured to identify one or more additional diseases/disorders/injuries for which a previously identified idealized thermal waveform is likely to be an effective treatment (e.g., by identifying, in a population of patients receiving treatment with an idealized thermal waveform for treatment of a first disease/disorder/injury, one or more co-morbid diseases/disorders/injuries that also appear to be effectively treated by the idealized thermal waveform).
  • the feedback module may be configured to identify one or more diseases/disorders/injuries for which a previously identified idealized thermal waveform is not likely to be an effective treatment (e.g., one or more of the diseases/disorders/injuries for which an idealized thermal waveform had previously been indicated and/or approved may be removed from the list of indications for that thermal waveform or for the class of thermal waveforms to which it belongs).
  • the feedback module is configured to transmit data associated with its analysis to a feedback database residing in the physician support device, to a patient information database residing in the physician support device, to a vestibular stimulation device, to a patient control device, to a physician control device and/or to a portable memory device (e.g. , an SD memory card).
  • a feedback database residing in the physician support device
  • a patient information database residing in the physician support device
  • a vestibular stimulation device to a patient control device
  • a physician control device to a physician control device and/or to a portable memory device (e.g. , an SD memory card).
  • the physician support device comprises an alert generation module configured to generate one or more alert messages.
  • the alert generation module may be configured to generate any suitable alert message, including, but not limited to, an alert indicating that physician feedback data has been received from a physician control device; a reminder to analyze previously received physician feedback data; an alert indicating that one or more idealized thermal waveforms has been modified and an alert indicating that a given modification is likely to increase/decrease the effectiveness of a given thermal waveform and/or an alert indicating that a given thermal waveform, class of thermal waveforms or combination of thermal waveforms has been identified as being indicated and/or approved for use in the treatment of a disease/disorder.
  • an alert indicating that physician feedback data has been received from a physician control device a reminder to analyze previously received physician feedback data
  • an alert indicating that one or more idealized thermal waveforms has been modified and an alert indicating that a given modification is likely to increase/decrease the effectiveness of a given thermal waveform and/or an alert indicating that a given thermal waveform, class of thermal waveforms or combination of thermal waveforms has been identified as being indicated and
  • the alert generation module is configured to communicate with various devices/modules, including, but not limited to, a vestibular stimulation device, a patient control device, a physician control device, a registry, a portable memory device (e.g., an SD memory card) and other modules of the physician support device.
  • the alert generation module may be configured to provide instructions to the GUI module and/or the tone generation module for displaying one or more alert messages and/or for generation an audible tone to alert a user of the presence of the one or more alert messages.
  • the graphical user interface module may be configured to display the one or more alert messages immediately upon generation or upon interaction with a user (e.g., an alert notification icon may be generated, with the alert message being displayed only after the user indicates that he/she wishes to view the message).
  • the physician support device comprises a tone generation module configured to produce audible tones.
  • the tone generation module comprises a piezo buzzer.
  • Audible tones may be produced to alert a user to various circumstances/events, including, but not limited to, the existence of an unread/unviewed alert message. Audible tones may be generated repeatedly in response to a single circumstance/event (e.g. , an audible tone may be generated repeatedly until the user views/reads the message) and may become progressively louder and/or more frequent with time.
  • the physician support device comprises a visual indicator module configured to notify a user of the existence of an unread/unviewed alert message.
  • the visual indicator module comprises an LED indicator light.
  • the visual indicator module may be activated repeatedly in response to a single alert message (e.g., an LED light may be illuminated repeatedly until the user views/reads the message) or may remain activated until the user views/reads the message.
  • the physician support device comprises a security module configured to prevent unauthorized use of the physician support device (i.e., to prevent unauthorized persons from using the physician support device, to prevent authorized persons from using the physician support device in an unauthorized manner, etc.).
  • the security module may be configured to prevent unauthorized use of the physician support device using any suitable means of security, including, but not limited to, password protection and data encryption.
  • the security module may be configured such that a user is required to input a designated password prior to generating and/or modifying a thermal waveform; generating, modifying, updating and/or extending a prescription; entering/viewing patient feedback data; viewing/analyzing physician feedback data and/or entering/viewing patient information (as discussed above with respect to Figure 12).
  • the physician support device may comprise any suitable data, including, but not limited to, static and/or dynamic data used by the operating system, applications, I O device drivers and other software components, controller feedback data, data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g. , idealized thermal waveforms), data associated with one or more prescriptions, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and patient information.
  • thermal waveforms e.g. , idealized thermal waveforms
  • the physician support device may comprise a waveform database comprising data associated with one or more idealized thermal waveforms; a prescription database comprising data associated with one or more prescriptions; a feedback database comprising controller feedback data, data associated with the delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of a patient, patient feedback data and physician feedback data and/or a patient history database comprising data associated with one or more patients.
  • a waveform database comprising data associated with one or more idealized thermal waveforms
  • a prescription database comprising data associated with one or more prescriptions
  • a feedback database comprising controller feedback data, data associated with the delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of a patient, patient feedback data and physician feedback data and/or a patient history database comprising data associated with one or more patients.
  • a feedback database comprising controller feedback data, data associated with the delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of a patient, patient feedback
  • one of the aforementioned databases is split into two or more distinct databases (e.g. , the physician support device may comprise a delivery feedback database comprising data associated with the specific parameters of the thermal waveform(s) delivered to a patient, a patient feedback database comprising patient feedback data and a physician feedback database comprising physician feedback data).
  • the physician support device may comprise a delivery feedback database comprising data associated with the specific parameters of the thermal waveform(s) delivered to a patient, a patient feedback database comprising patient feedback data and a physician feedback database comprising physician feedback data).
  • one or more of the data types described below with respect to one of the databases described below is stored in one of the other databases described below (e.g., the patient information database, rather than the feedback database, may be configured to receive/store patient feedback data).
  • data is transmitted, received and/or stored in a controlled format (e.g., in a standardized format using forms/programs supplied by the physician support device or a registry).
  • the physician support device may be configured to transmit, receive and store data in a manner that ensures compliance with any and all applicable laws and/or regulations (e.g. , the Health Insurance Portability and Accountability Act of 1996 (P.L. 104-191; "HIPAA”)).
  • HIPAA Health Insurance Portability and Accountability Act
  • the physician support device comprises a waveform database configured to receive, store and/or transmit data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g, one or more idealized thermal waveforms).
  • the waveform database is configured such that one or more of the thermal waveforms stored therein is/are protected (e.g., users may be prevented from modifying and/or deleting the idealized thermal waveform(s) stored in the waveform database).
  • the waveform database may comprise any suitable type of memory including, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.
  • the waveform database comprises a portable memory device, such as an SD memory card or a USB memory stick.
  • the waveform database may comprise an SD memory card interface and one or more prescriptions may be stored on a portable SD memory card.
  • the waveform database may be configured to receive and/or transmit data from/to any suitable device/module/database, including, but not limited to, modules residing in the physician support device, a vestibular stimulation device, a patient control device, a physician control device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • the waveform database may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the physician support device comprises a prescription database configured to receive, transmit and/or store one or more prescriptions, wherein each prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • the prescription database may comprise any suitable type of memory including, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.
  • the prescription database comprises a portable memory device, such as an SD memory card or a USB memory stick.
  • the prescription database may comprise an SD memory card interface and one or more prescriptions may be stored on a portable SD memory card.
  • the prescription database may be configured to receive and/or transmit data from/to any suitable device/module/database, including, but not limited to, modules residing in the physician support device, a vestibular stimulation device, a patient control device, a physician control device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • modules residing in the physician support device including, but not limited to, modules residing in the physician support device, a vestibular stimulation device, a patient control device, a physician control device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • the prescription database may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the physician support device comprises a feedback database configured to receive, transmit and/or store feedback data.
  • the feedback database may comprise any suitable type of memory including, but not limited to, cache,
  • the feedback database comprises a portable memory device, such as an SD memory card or a USB memory stick.
  • the feedback database may comprise an SD memory card interface and one or more prescriptions may be stored on a portable SD memory card.
  • the feedback database may be configured to receive and/or transmit feedback data from/to any suitable device/module/database, including, but not limited to, modules residing in the physician support device, a vestibular stimulation device, a patient control device, a physician control device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • modules residing in the physician support device including, but not limited to, modules residing in the physician support device, a vestibular stimulation device, a patient control device, a physician control device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • the feedback database may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • Feedback data may comprise any suitable data, including, but not limited to, controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and/or patient information.
  • the feedback database may comprise a log file detailing the target time/temperature parameters of one or more prescribed thermal waveform(s); the time/temperature parameters of the thermal waveform(s) delivered to a patient; the date/time of delivery of the thermal waveform(s) delivered to a patient; the temperature(s) of a patient's ear canal(s) at various time points before, during and/or after delivery of one or more thermal waveforms; the temperature(s) of a patient's inner ear(s) at various time points before, during and/or after delivery of one or more thermal waveforms; the fit of one or more earpieces at various time points before, during and/or after delivery of one or more thermal waveforms; an estimate of the thermal contact between one or more earpieces and a
  • the physician support device comprises a patient history database configured to receive, transmit and/or store patient information.
  • the patient history database may comprise any suitable type of memory including, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.
  • the patient history database comprises a portable memory device, such as an SD memory card or a USB memory stick.
  • the patient history database may comprise an SD memory card interface and one or more prescriptions may be stored on a portable SD memory card.
  • the patient history database may be configured to receive and/or transmit data from/to any suitable device/module/database, including, but not limited to, modules residing in the physician support device, a vestibular stimulation device, a patient control device, a physician control device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • modules residing in the physician support device including, but not limited to, modules residing in the physician support device, a vestibular stimulation device, a patient control device, a physician control device, a registry, a TED, a sensor and a portable memory device (e.g., an SD memory card).
  • the patient history database may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • Patient information may comprise any suitable information that is associated with a patient, including, but not limited to, the patient's medical history, the patient's current symptoms (if any),the patient's present diagnosis (if any), the patient's current prescriptions (if any) and data associated with the delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of the patient.
  • the physician support device may comprise any I/O device drivers, including, but not limited to, software routines accessed through the operating system by the applications to communicate with devices such as I/O ports, memory components, vestibular stimulation devices, patient control devices and/or physician control devices.
  • the physician support device may be configured (e.g., with computer instructions (i.e., software)) to operate in a plurality of distinct modes. In each mode, the physician support device may be configured to permit access to some functionalities/modules and to prevent access to other functionalities/modules.
  • the physician support device may be configured to operate in a researcher mode, wherein the user is allowed to perform researcher-oriented tasks, such as generating and/or modifying the parameters, indications and/or approvals of one or more idealized thermal waveforms, but is prevented from accessing other functionalities/modules (e.g., the user may be prevented from modifying the underlying operational parameters of the physician control device).
  • the physician support device may be configured to operate in an engineer mode, wherein the user is allowed to access all of the physician support device's functionalities/modules.
  • Each mode may be protected via a unique security measure (e.g., the physician support device may be configured such that each mode is protected by a unique password).
  • the physician support device 4 comprises memory 40, a processor 41 and a power supply 42 (e.g., an internal power supply), wherein memory 40 is representative of the overall hierarchy of memory devices containing software and data used to implement the functionality of the physician support device 4 and wherein the processor 41 communicates with the memory 40 via an address/data bus 400.
  • memory 40 comprises an operating system 40a, applications 40b (e.g.
  • a waveform module 4a configured to generate and/or modify the parameters, indications and/or approvals of one or more thermal waveforms
  • a treatment module 4b configured to generate, modify, update and/or extend a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient
  • a network module 4d configured to receive and/or transmit data
  • a GUI module 4e configured to display information and/or accept user input and/or a feedback module 4f configured to receive, transmit, and/or analyze data associated with the delivery of one or more thermal waveforms
  • data 40c e.g., a waveform database 4h comprising data associated with the parameters, indications and/or approvals of one or more thermal waveforms
  • a prescription database 4i comprising at least one prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient
  • a feedback database 4j comprising data associated with
  • data 40c comprises one or more databases stored on a portable memory device.
  • data 40c may comprise an SD memory card interface and a portable SD memory card comprising a waveform database 4h, a prescription database 4i, a feedback database 4j and/or a patient history database 4k.
  • the waveform module 4a is configured to update the waveform database 4h by adding a newly generated idealized thermal waveform, by modifying one or more of the idealized thermal waveforms stored therein, by deleting one or more of the idealized thermal waveforms stored therein and/or by modifying the indication/approvals associated with one or more of the idealized thermal waveforms stored therein in response to the analysis of data (e.g., physician feedback data) by the feedback module 4f.
  • data e.g., physician feedback data
  • the network module 4d is configured to receive data associated with the parameters, indications and/or approvals of one or more thermal waveforms from the waveform module 4a, a patient control device, a physician control device, a registry and/or a portable memory device (e.g., an SD memory card) and to transmit the data to the waveform database 4h for storage.
  • the data is stored on an SD memory card inserted into an SD memory card interface.
  • the network module 4d is configured to retrieve data associated with the parameters, indications and/or approvals of one or more thermal waveforms from the waveform database 4h, a registry and/or a portable memory device (e.g., an SD memory card) and to transmit the data to the waveform module 4a, the treatment module 4b, a vestibular stimulation device, a patient control device, a physician control device, a registry and/or a portable memory device (e.g., an SD memory card).
  • a registry and/or a portable memory device e.g., an SD memory card
  • the physician support device is configured to transmit all of the idealized thermal waveforms in the waveform database or a subset thereof (e.g., waveforms indicated for use in the treatment of migraines) to one or more physician control devices upon request (e.g., after receiving an update request from a physician control device) or at a specified interval (e.g. , every two weeks).
  • the physician support device is configured to replace the idealized thermal waveforms in a physician control device's waveform database with the idealized thermal waveforms from the physician support device's waveform database.
  • the network module 4d is configured to receive one or more prescriptions from the treatment module 4b, a patient control device, a physician control device, a registry and/or a portable memory device (e.g. , an SD memory card) and to transmit the prescription(s) to the prescription database 4i for storage.
  • the prescription(s) is/are stored on an SD memory card inserted into an SD memory card interface.
  • the network module 4d is configured to retrieve one or more prescriptions from the prescription database 4i, a registry and/or a portable memory device (e.g. , an SD memory card) and to transmit the prescription(s) to the treatment module 4b, a vestibular stimulation device, a patient control device, a physician control device, a registry and/or a portable memory device (e.g. , an SD memory card).
  • a portable memory device e.g. , an SD memory card
  • the network module 4d is configured to receive data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data and/or physician feedback data from a vestibular stimulation device, a patient control device, a physician control device, a registry and/or a portable memory device (e.g., an SD memory card) and to transmit that data to the feedback database 4j for storage.
  • the data is stored on an SD memory card inserted into an SD memory card interface.
  • the network module 4d is configured to retrieve data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data and/or physician feedback data from the feedback database 4j and to transmit the data to the feedback module 4f, a physician control device, a registry and/or a portable memory device (e.g., an SD memory card).
  • the network module 4d is configured to receive patient information from the GUI module 4e, a vestibular stimulation device, a patient control device, a physician control device, a registry and/or a portable memory device (e.g., an SD memory card) and to transmit that data to the patient history database 4k for storage.
  • the patient information is stored on an SD memory card inserted into an SD memory card interface.
  • the network module 4d is configured to retrieve patient information from the patient history database 4k and to transmit the patient information to a physician control device, a registry and/or a portable memory device (e.g., an SD memory card).
  • the feedback module 4f is configured to analyze data from the waveform database 4h, the prescription database 4i, the feedback database 4j and/or the patient history database 4k to identify diseases/disorders/injuries for which a given thermal waveform, class of thermal waveforms, combination of thermal waveforms and/or treatment regimen may be an effective treatment.
  • the feedback module 4d is configured to automatically initiate such data analysis each time one of the aforementioned databases is modified or at a predetermined interval (e.g., every two weeks).
  • the feedback module 4d is configured to communicate the results of its analysis to the waveform module 4a (e.g., by transmitting the results to the waveform module 4a via the network module 4d) and/or to a registry.
  • the present invention provides a registry for receiving, storing and/or transmitting data.
  • the registry comprises, consists essentially of or consists of a network module configured to receive/transmit data and one or more databases configured to store data.
  • a registry of the present invention may comprise any suitable computing device/system, including, but not limited to, a desktop computer, a laptop computer, a handheld computer, a personal digital assistant (PDA), and a smart phone.
  • a desktop computer including, but not limited to, a desktop computer, a laptop computer, a handheld computer, a personal digital assistant (PDA), and a smart phone.
  • PDA personal digital assistant
  • any conventional security means may be provided to prevent unauthorized activation of the registry.
  • the registry may be password protected.
  • the registiy may be configured to receive and/or transmit any suitable data, including, but not limited to, data associated with the parameters, indications and/or approvals of one or more thermal waveforms, one or more prescriptions, controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and/or patient information.
  • data associated with the parameters, indications and/or approvals of one or more thermal waveforms, one or more prescriptions controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and/or patient information.
  • the registry may be configured to receive and/or transmit data from/to various devices, including, but not limited to, a vestibular stimulation device, a patient control device, a physician control device, a physician support device and a portable memory device (e.g. , an SD memory card).
  • the registry is configured to receive data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g., idealized thermal waveforms) from a vestibular stimulation device, a patient control device, a physician control device, a physician support device, another registry and/or a portable memory device (e.g., an SD memory card); to transmit data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g.
  • a thermal waveforms e.g., idealized thermal waveforms
  • idealized thermal waveforms to a vestibular stimulation device, a patient control device, a physician control device, a physician support device, another registry and/or a portable memory device (e.g., an SD memory card); to receive feedback data and/or patient information from a vestibular stimulation device, a patient control device, a physician control device, a physician support device, another registry and/or a portable memory device (e.g., an SD memory card); and/or to transmit feedback data and/or patient information to a vestibular stimulation device, a patient control device, a physician control device, a physician support device, another registry and/or a portable memory device (e.g. , an SD memory card).
  • a portable memory device e.g., an SD memory card
  • the registry is configured to receive, store and/or transmit data from/to one or more devices located within a specified geographical region (e.g., one or more physician control devices located within the United States, one or more physician support devices located within North America, etc.).
  • a specified geographical region e.g., one or more physician control devices located within the United States, one or more physician support devices located within North America, etc.
  • the registry may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the registry comprises memory, a processor and a power supply.
  • the processor may be any commercially available or custom microprocessor.
  • Memory can include, but is not limited to, the following types of devices: cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.
  • the power supply may be an internal power supply (e.g., one or more rechargeable batteries that may be recharged without first being removed from the registry).
  • the registry's memory may comprise any suitable software and/or data, including, but not limited to, an operating system, applications, data and input/output (I/O) drivers.
  • the registry may use any suitable operating system, including, but not limited to, OS/2, AIX, OS/390 or System390 from International Business Machines Corp. (Armonk, NY), Window CE, Windows NT, Windows95, Windows98, Windows2000, Windows 7 or Windows Vista from Microsoft Corp. (Redmond, WA), Mac OS from Apple, Inc. (Cupertino, CA), Unix, Linux or Android.
  • the registry may comprise any suitable application, including, but not limited to, one or more programs configured to implement one or more of the various features of the present invention.
  • the registry may comprise a network module configured to receive and/or transmit data, a GUI module configured to display information and/or accept user input, an alert generation module configured to generate one or more alert messages; a tone generation module configured to produce one or more audible tones; a visual indicator module configured to produce one or more visual indicators and/or a security module configured to prevent unauthorized use of the registry.
  • the registry comprises a network module configured to receive, retrieve and/or transmit data.
  • the network module may be configured to receive, retrieve and/or transmit data from/to any suitable device/module/database, including, but not limited to, other modules residing in the registry, databases residing in the registry, a vestibular stimulation device, a patient control device, a physician control device, a physician support device, another registry and a portable memory device (e.g., an SD memory card).
  • a portable memory device e.g., an SD memory card
  • the network module may be configured to receive, retrieve and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the network module may be configured to receive, retrieve and/or transmit any suitable data, including, but not limited to, data associated with the parameters, indications and/or approvals of one or more thermal waveforms, one or more prescriptions, controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and/or patient information.
  • the network module is configured to receive and/or retrieve data associated with the parameters, indications and/or approvals of one or more thermal waveforms from a waveform database residing in the registry, from a vestibular stimulation device, from a patient control device, from a physician control device, from a physician support device, from another registry and/or from a portable memory device.
  • the network module is configured to receive and/or retrieve one or more prescriptions from a prescription database residing in the registry, from a vestibular stimulation device, from a patient control device, from a physician control device, from a physician support device, from another registry and/or from a portable memory device.
  • the network module is configured to receive and/or retrieve controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and/or patient information from a feedback database residing in the registry, from a vestibular stimulation device, from a patient control device, from a physician control device, from a physician support device, from another registry and/or from a portable memory device.
  • the network module is configured to transmit data associated with the parameters, indications and/or approvals of one or more thermal waveforms to a waveform database residing in the registry, to a vestibular stimulation device, to a patient control device, to a physician control device, to a physician support device, to another registry and/or to a portable memory device.
  • the network module is configured to transmit one or more prescriptions to a prescription database residing in the registry, to a vestibular stimulation device, to a patient control device, to a physician control device, to a physician support device, to another registry and/or to a portable memory device.
  • the network module is configured to transmit controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and/or patient information to a feedback database residing in the registry, to a vestibular stimulation device, to a patient control device, to a physician control device, to a physician support device, to another registry and/or to a portable memory device.
  • the network module is configured to access a database comprising data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g., idealized thermal waveforms).
  • the network module maybe configured to access a waveform database residing in a vestibular stimulation device, a waveform database residing in a patient control device, a waveform database residing in a physician control device, a waveform database residing in a physician support device, a waveform database residing in the registry, a waveform database residing in another registry and/or a waveform database residing in a portable memory device.
  • the network module is configured to access a database comprising one or more prescriptions.
  • the network module maybe configured to access a prescription database residing in a vestibular stimulation device, a prescription database residing in a patient control device, a prescription database residing in a physician control device, a prescription database residing in a physician support device, a prescription database residing in the registry, a prescription database residing in another registry and/or a prescription database residing in a portable memory device.
  • the network module is configured to access a database comprising controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data and/or physician feedback data.
  • the network module maybe configured to access a feedback database residing in a vestibular stimulation device, a feedback database residing in a patient control device, a feedback database residing in a physician control device, a feedback database residing in a physician support device, a feedback database residing in the registry, a feedback database residing in another registry and/or a feedback database residing in a portable memory device.
  • the network module is configured to access a database comprising patient information.
  • the network module maybe configured to access a patient information database residing in a vestibular stimulation device, a patient information database residing in a patient control device, a patient information database residing in a physician control device, a patient information database residing in a physician support device, a patient information database residing in the registry, a patient information database residing in another registry and/or a patient information database residing in a portable memory device.
  • the registry comprises a GUI module configured to display information and/or to accept user input.
  • GUI Any suitable GUI may be used, including, but not limited to, a keyboard, a mouse, an LCD display with one or more associated entry keys and an interactive touch screen.
  • the GUI may comprise a static pressure touch-sensitive display, a capacitive touch-sensitive display, a resistive touch-sensitive display, an electrostatic capacity proximity sensor, a magnetic proximity sensor and /or an infrared proximity sensor. See, e.g., U.S. Patent Publication Nos. 2011/0271222, 2011/0273575, 2011/0275414 and 2011/0275416.
  • the GUI module may be configured to display any suitable information, including, but not limited to, data associated with the parameters, indications and/or approvals of one or more thermal waveforms.
  • the GUI module may be configured to display one or more prescribed thermal waveforms; the precise time/temperature parameters of the thermal waveform(s) delivered to a patient; the date/time of delivery of the thermal waveform(s) delivered to a patient; the temperature(s) of a patient's ear canal(s) at various time points before, during and/or after delivery of the thermal waveform(s); the temperature(s) of a patient's inner ear(s) at various time points before, during and/or after delivery of the thermal waveform(s); the fit of the earpiece(s) at various time points before, during and/or after delivery of the thermal waveform(s); an estimate of the thermal contact between the earpiece(s) and the patient's ear canal(s) at various time points before, during and/or after delivery of the thermal waveform(s); patient-specific time
  • the instability of a treatment ⁇ i.e., which symptom(s) returned and when did it/they return); the presence or absence of comorbid disorders, injuries and/or diseases; disorder, injury and/or disease modulation(s) and/or modification(s) that occurred as a result of treatment; the cognitive effect(s) of one or more thermal waveforms; patient compliance ⁇ e.g., whether a patient initiated delivery at the prescribed time, whether a patient completed the prescribed treatment session, whether the earpiece(s) remained properly fitted in a patient's ear canal(s) for the duration of the treatment session, etc.); the mood of a patient at various time points before, during and/or after delivery of one or more thermal waveforms (e.g., videos/images of a patient that may be used to assess mood); objectives measures of efficacy (e.g., nystamography data, EEG data, MRI data, heart rate data, blood pressure data); subjective measures of efficacy
  • a patient- reported pain score e.g., blood Ale levels, blood glucose levels and blood Cortisol levels
  • saliva chemistry data e.g., saliva Cortisol levels
  • urine chemistry data e.g. , urine Cortisol levels
  • comments a patient made about his/her treatment session(s) e.g., comments made to a physician, submitted in response to an automated survey and/or recorded in a treatment diary
  • the impedance between an earpiece inserted into the ear canal of a patient and an electrode affixed to a second location on/in said patient's body e.g., an electrode placed in or adjacent to the patient's other ear canal
  • the rate at which a patient's inner ear cools in response to a cooling stimulus e.g., data from a temperature sensor, such as thermistor, that monitors how quickly the inner ear cools in response to a cooling waveform
  • a temperature sensor such as thermistor, that monitors how quickly the inner ear warms in response to a warming waveform
  • patient comments regarding the subjective fit of his/her earpiece(s)
  • physician comments regarding the effectiveness of one or more thermal waveforms and/or physician comments regarding the effect(s) of one or more waveform modifications.
  • the GUI module may be configured to accept any suitable user input, including, but not limited to, instructions for transmitting the parameters, indications and/or approvals of a thermal waveforms to one or more vestibular stimulation devices, one or more patient control devices, one or more physician control devices and/or one or more physician support devices.
  • the registry comprises an alert generation module configured to generate one or more alert messages.
  • the alert generation module may be configured to generate any suitable alert message, including, but not limited to, an alert indicating that data has been received and an alert indicating that a request for data has been received.
  • the alert generation module is configured to communicate with various devices/modules, including, but not limited to, a vestibular stimulation device, a patient control device, a physician control device, a physician support device, another regsitry, a portable memory device (e.g., an SD memory card) and other modules of the registry.
  • the alert generation module may be configured to provide instructions to the GUI module and/or the tone generation module for displaying one or more alert messages and/or for generation an audible tone to alert a user of the presence of the one or more alert messages.
  • the graphical user interface module may be configured to display the one or more alert messages immediately upon generation or upon interaction with a user (e.g. , an alert notification icon may be generated, with the alert message being displayed only after the user indicates that he/she wishes to view the message).
  • the registry comprises a tone generation module configured to produce audible tones.
  • the tone generation module comprises a piezo buzzer.
  • Audible tones may be produced to alert a user to various circumstances/events, including, but not limited to, the existence of an unread/unviewed alert message. Audible tones may be generated repeatedly in response to a single circumstance/event (e.g., an audible tone may be generated repeatedly until the user views/reads the message) and may become progressively louder and/or more frequent with time.
  • the registry comprises a visual indicator module configured to notify a user of the existence of an unread/unviewed alert message.
  • the visual indicator module comprises an LED indicator light.
  • the visual indicator module may be activated repeatedly in response to a single alert message (e.g., an LED light may be illuminated repeatedly until the user views/reads the message) or may remain activated until the user views/reads the message.
  • the registry comprises a security module configured to prevent unauthorized use of the registry (i.e., to prevent unauthorized persons from using the registry, to prevent authorized persons from using the registry in an unauthorized manner, etc.).
  • the security module may be configured to prevent unauthorized use of the registry using any suitable means of security, including, but not limited to, password protection and data encryption.
  • the security module may be configured such that a user is required to input a designated password prior to accessing the waveform database; entering/viewing patient feedback data; entering/viewing physician feedback data and/or entering/viewing patient information (as discussed above with respect to Figure 12).
  • the registry may comprise any suitable data, including, but not limited to, static and/or dynamic data used by the operating system, applications, I/O device drivers and other software components, controller feedback data, data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g., idealized thermal waveforms), data associated with one or more prescriptions, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and patient information.
  • thermal waveforms e.g., idealized thermal waveforms
  • the registry may comprise a waveform database comprising data associated with one or more idealized thermal waveforms; a prescription database comprising data associated with one or more prescriptions; a feedback database comprising controller feedback data, data associated with the delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of a patient, patient feedback data and physician feedback data and/or a patient history database comprising data associated with one or more patients.
  • a waveform database comprising data associated with one or more idealized thermal waveforms
  • a prescription database comprising data associated with one or more prescriptions
  • a feedback database comprising controller feedback data, data associated with the delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of a patient, patient feedback data and physician feedback data and/or a patient history database comprising data associated with one or more patients.
  • a feedback database comprising controller feedback data, data associated with the delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of a patient, patient feedback data and
  • one of the aforementioned databases is split into two or more distinct databases (e.g., the registry may comprise a delivery feedback database comprising data associated with the specific parameters of the thermal waveform(s) delivered to a patient, a patient feedback database comprising patient feedback data and a physician feedback database comprising physician feedback data).
  • the data types described below with respect to one of the databases described below is stored in one of the other databases described below (e.g. , the patient information database, rather than the feedback database, may be configured to receive/store patient feedback data).
  • data is transmitted, received and/or stored in a controlled format (e.g., in a standardized format using forms/programs supplied by a physician support device or a registry).
  • the registry may be configured to transmit, receive and store data in a manner that ensures compliance with any and all applicable laws and/or regulations (e.g., the Health Insurance Portability and Accountability Act of 1996 (P.L. 104-191; "HIPAA”)).
  • HIPAA Health Insurance Portability and Accountability Act
  • the registry comprises a waveform database configured to receive, store and/or transmit data associated with the parameters, indications and/or approvals of one or more thermal waveforms ⁇ e.g, one or more idealized thermal waveforms).
  • the waveform database is configured such that one or more of the thermal waveforms stored therein is/are protected (e.g., users may be prevented from modifying and/or deleting the idealized thermal waveform(s) stored in the waveform database).
  • the waveform database may comprise any suitable type of memory including, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.
  • the waveform database comprises a portable memory device, such as an SD memory card or a USB memory stick.
  • the waveform database may comprise an SD memory card interface and one or more prescriptions may be stored on a portable SD memory card.
  • the waveform database may be configured to receive and/or transmit data from/to any suitable device/module/database, including, but not limited to, modules residing in the registry, a vestibular stimulation device, a patient control device, a physician control device, a physician support device, another registry and a portable memory device (e.g., an SD memory card).
  • modules residing in the registry including, but not limited to, modules residing in the registry, a vestibular stimulation device, a patient control device, a physician control device, a physician support device, another registry and a portable memory device (e.g., an SD memory card).
  • the registry is configured to receive, store and/or transmit data associated with the parameters, indications and/or approvals of one or more thermal waveforms (e.g, one or more idealized thermal waveforms)from/to one or more devices located within a specified geographical region.
  • the waveform database may be configured to receive, store and/or transmit data associated with the parameters, indications and/or approvals of one or more idealized, actively controlled, time-varying thermal waveforms from/to one or more physician control devices and/or one or more physician support devices located within a specified geographical region (e.g., the northeastern United States, the southeastern United States, the United States, North America, Europe, Japan, China, etc.).
  • the waveform database may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the registry comprises a prescription database configured to receive, transmit and/or store one or more prescriptions, wherein each prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • the prescription database may comprise any suitable type of memory including, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.
  • the prescription database comprises a portable memory device, such as an SD memory card or a USB memory stick.
  • the prescription database may comprise an SD memory card interface and one or more prescriptions may be stored on a portable SD memory card.
  • the prescription database may be configured to receive and/or transmit data from/to any suitable device/module/database, including, but not limited to, modules residing in the registry, a vestibular stimulation device, a patient control device, a physician control device, a physician support device, another registry and a portable memory device (e.g. , an SD memory card).
  • modules residing in the registry including, but not limited to, modules residing in the registry, a vestibular stimulation device, a patient control device, a physician control device, a physician support device, another registry and a portable memory device (e.g. , an SD memory card).
  • the registry is configured to receive, store and/or transmit data associated with one or more prescriptions from/to one or more devices located within a specified geographical region.
  • the prescription database may be configured to receive, store and/or transmit data associated with one or more prescriptions from/to one or more physician control devices and/or one or more physician support devices located within a specified geographical region (e.g., the northeastern United States, the southeastern United States, the United States, North America, Europe, Japan, China, etc.).
  • the prescription database may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the registry comprises a feedback database configured to receive, transmit and/or store feedback data.
  • the feedback database may comprise any suitable type of memory including, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.
  • the feedback database comprises a portable memory device, such as an SD memory card or a USB memory stick.
  • the feedback database may comprise an SD memory card interface and one or more prescriptions may be stored on a portable SD memory card.
  • the feedback database may be configured to receive and/or transmit feedback data from/to any suitable device/module/database, including, but not limited to, modules residing in the physician support device, a vestibular stimulation device, a patient control device, a physician control device, a physician support device, another registry and a portable memory device (e.g., an SD memory card).
  • modules residing in the physician support device including, but not limited to, modules residing in the physician support device, a vestibular stimulation device, a patient control device, a physician control device, a physician support device, another registry and a portable memory device (e.g., an SD memory card).
  • the registry is configured to receive, store and/or transmit feedback data from/to one or more devices located within a specified geographical region.
  • the feedback database may be configured to receive, store and/or transmit feedback from/to one or more physician control devices and/or one or more physician support devices located within a specified geographical region (e.g., the northeastern United States, the southeastern United States, the United States, North America, Europe, Japan, China, etc.).
  • the feedback database may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • Feedback data may comprise any suitable data, including, but not limited to, controller feedback data, data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data, physician feedback data and/or patient information.
  • the feedback database may comprise a log file detailing the target time/temperature parameters of one or more prescribed thermal waveform(s); the time/temperature parameters of the thermal waveform(s) delivered to a patient; the date/time of delivery of the thermal waveform(s) delivered to a patient; the temperature(s) of a patient's ear canal(s) at various time points before, during and/or after delivery of one or more thermal waveforms; the temperature(s) of a patient's inner ear(s) at various time points before, during and/or after delivery of one or more thermal waveforms; the fit of one or more earpieces at various time points before, during and/or after delivery of one or more thermal waveforms; an estimate of the thermal contact between one or more earpieces and a
  • videos/images of a patient that may be used to assess mood
  • objectives measures of efficacy e.g., nystamography data, EEG data, MRI data, heart rate data, blood pressure data
  • subjective measures of efficacy e.g., a patient-reported pain score
  • blood chemistry data e.g.
  • a patient made about his/her treatment session(s) e.g., comments made to a physician, submitted in response to an automated survey and/or recorded in a treatment diary
  • the impedance between an earpiece inserted into the ear canal of a patient and an electrode affixed to a second location on/in said patient's body e.g., an electrode placed in or adjacent to the patient's other ear canal
  • the rate at which an earpiece is cooled in response to a cooling stimulus e.g., data from a temperature sensor, such as thermistor, that monitors how quickly the earpiece cools in response to a cooling waveform
  • the rate at which an earpiece is warmed in response to a warming stimulus e.g., data from a temperature sensor, such as a thermistor
  • the registry comprises a patient history database configured to receive, transmit and/or store patient information.
  • the patient history database may comprise any suitable type of memory including, but not limited to, cache, ROM, PROM, EPROM, EEPROM, flash memory, SRAM and DRAM.
  • the patient history database comprises a portable memory device, such as an SD memory card or a USB memory stick.
  • the patient history database may comprise an SD memory card interface and one or more prescriptions may be stored on a portable SD memory card.
  • the patient history database may be configured to receive and/or transmit data from/to any suitable device/module/database, including, but not limited to, modules residing in the registry, a vestibular stimulation device, a patient control device, a physician control device, a physician support device, another registry and a portable memory device (e.g., an SD memory card).
  • modules residing in the registry including, but not limited to, modules residing in the registry, a vestibular stimulation device, a patient control device, a physician control device, a physician support device, another registry and a portable memory device (e.g., an SD memory card).
  • the registry is configured to receive, store and/or transmit patient information from to one or more devices located within a specified geographical region.
  • the patient history database may be configured to receive, store and/or transmit patient information from/to one or more physician control devices and/or one or more physician support devices located within a specified geographical region (e.g., the northeastern United States, the southeastern United States, the United States, North America, Europe, Japan, China, etc.).
  • the patient history database may be configured to receive and/or transmit data over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • Patient information may comprise any suitable information that is associated with a patient, including, but not limited to, the patient's medical history, the patient's current symptoms (if any),the patient's present diagnosis (if any), the patient's current prescriptions (if any) and data associated with the delivery of one or more thermal waveforms to the vestibular system and/or the nervous system of the patient.
  • the registry may comprise any I O device drivers, including, but not limited to, software routines accessed through the operating system by the applications to communicate with devices such as I/O ports, memory components, vestibular stimulation devices, patient control devices, physician control devices and/or physician support devices.
  • the registry may be configured (e.g., with computer instructions (i.e., software)) to operate in a plurality of distinct modes.
  • the registry may be configured to permit access to some functionalities/modules and to prevent access to other functionalities/modules.
  • the registry may be configured to operate in a researcher mode, wherein the user is allowed to perform researcher-oriented tasks, such as uploading and/or downloading data associated with the parameters, indication and/or approvals of one or more idealized thermal waveforms, but is prevented from accessing other functionalities/modules (e.g., the user may be prevented from modifying the underlying operational parameters of the registry).
  • the registry may be configured to operate in an engineer mode, wherein the user is allowed to access all of the registry's functionalities/modules.
  • Each mode may be protected via a unique security measure (e.g., the registry may be configured such that each mode is protected by a unique password).
  • the registry 5 comprises memory 50, a processor 51 and a power supply 52 (e.g., an internal power supply), wherein memory 50 is representative of the overall hierarchy of memory devices containing software and data used to implement the functionality of the registry 5 and wherein the processor 51 communicates with the memory 50 via an address/data bus 500.
  • a power supply 52 e.g., an internal power supply
  • memory 50 comprises an operating system 50a, applications 50b (e.g., a network module 5d configured to receive and/or transmit data and/or a GUI module 5e configured to display information and/or accept user input), data 50c (e.g., a waveform database 5h comprising data associated with the parameters, indications and/or approvals of one or more thermal waveforms; a prescription database 5i comprising at least one prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient; a feedback database 5j comprising data associated with the delivery of one or more thermal waveforms and/or a patient history database 5k comprising patient information) and I O drivers 50d.
  • applications 50b e.g., a network module 5d configured to receive and/or transmit data and/or a GUI module 5e configured to display information and/or accept user input
  • data 50c e.g., a waveform database 5h comprising data associated with the parameters, indications and
  • data 50c comprises one or more databases stored on a portable memory device.
  • data 50c may comprise an SD memory card interface and a portable SD memory card comprising a waveform database 5h, a prescription database 5i, a feedback database 5j and/or a patient history database 5k.
  • the network module 5d is configured to receive data associated with the parameters, indications and/or approvals of one or more thermal waveforms from a vestibular stimulation device, a patient control device, a physician control device, a physician support device, another registry and/or a portable memory device (e.g., an SD memory card) and to transmit the data to the waveform database 5h for storage.
  • the network module 5d may be configured to receive data associated with the parameters, indications and/or approvals of one or more idealized, actively controlled, time-varying thermal waveforms from one or more physician control devices and/or one or more physician support devices located in a specified geographical region (e.g. , the northeastern United States, the southeastern United States, the United States, North America, Europe, Japan, China, etc.).
  • the network module 5d is configured to retrieve data associated with the parameters, indications and/or approvals of one or more thermal waveforms from the waveform database 5h and to transmit the data to a vestibular stimulation device, a patient control device, a physician control device, a physician support device, another registry and/or a portable memory device (e.g., an SD memory card).
  • the network module 5d may be configured to transmit data associated with the parameters, indications and/or approvals of one or more thermal waveforms from the waveform database 5h to one or more physician control devices and/or one or more physician support devices located in a specified geographical region (e.g., the northeastern United States, the southeastern United States, the United States, North America, Europe, Japan, China, etc.).
  • a specified geographical region e.g., the northeastern United States, the southeastern United States, the United States, North America, Europe, Japan, China, etc.
  • the physician support device is configured to transmit all of the idealized thermal waveforms in the waveform database or a subset thereof (e.g., waveforms indicated for use in the treatment of migraines) to one or more physician control devices and/or one or more physician support devices upon request (e.g., after receiving an update request from a physician support device) or at a specified interval (e.g. , every two weeks).
  • the registry is configured to replace the idealized thermal waveforms in a physician support device's waveform database with the idealized thermal waveforms from the registry's waveform database.
  • the network module 5d may be configured to update the waveform database(s) of one or more physician control devices and/or one or more physician support devices located in a specified geographical region (e.g., the northeastern United States, the southeastern United States, the United States, North America, Europe, Japan, China, etc.) by replacing the idealized thermal waveforms located therein with idealized thermal waveforms from the registry's waveform database.
  • the network module 5d is configured to receive one or more prescriptions from a vestibular stimulation device, a patient control device, a physician control device, a physician support device, another registry and/or a portable memory device (e.g., an SD memory card) and to transmit the prescription(s) to the prescription database 5i for storage.
  • the network module 5d may be configured to receive data associated with one or more prescriptions from one or more physician control devices and/or one or more physician support devices located in a specified geographical region (e.g., the northeastern United States, the southeastern United States, the United States, North America, Europe, Japan, China, etc.).
  • the network module 5d is configured to retrieve one or more prescriptions from the prescription database 5i and to transmit the prescription(s) to a vestibular stimulation device, a patient control device, a physician control device, a physician support device, another registry and/or a portable memory device (e.g., an SD memory card).
  • the network module 5d may be configured to transmit data associated with one or more prescriptions from the presription database 5i to one or more physician control devices and/or one or more physician support devices located in a specified geographical region (e.g., the northeastern United States, the southeastern United States, the United States, North America, Europe, Japan, China, etc.).
  • the network module 5d is configured to receive data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data and/or physician feedback data from a vestibular stimulation device, a patient control device, a physician control device, a physician support device, another registry and/or a portable memory device (e.g., an SD memory card) and to transmit that data to the feedback database 5j for storage.
  • the network module 5d may be configured to receive data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data and/or physician feedback data from one or more physician control devices and/or one or more physician support devices located in a specified geographical region (e.g., the northeastern United States, the southeastern United States, the United States, North America, Europe, Japan, China, etc.).
  • a specified geographical region e.g., the northeastern United States, the southeastern United States, the United States, North America, Europe, Japan, China, etc.
  • the network module 5d is configured to retrieve data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data and/or physician feedback data from the feedback database 5j and to transmit the data to a vestibular stimulation device, a patient control device, a physician control device, a physician support device, another registry and/or a portable memory device (e.g., an SD memory card).
  • the network module 5d may be configured to transmit data associated with the delivery of one or more thermal waveforms, data associated with the fit of one or more earpieces, patient feedback data and/or physician feedback data from the feedback database 5j to one or more physician control devices and/or one or more physician support devices located in a specified geographical region (e.g., the northeastern United States, the southeastern United States, the United States, North America, Europe, Japan, China, etc.).
  • a specified geographical region e.g., the northeastern United States, the southeastern United States, the United States, North America, Europe, Japan, China, etc.
  • the network module 5d is configured to receive patient information from a vestibular stimulation device, a patient control device, a physician control device, a physician support device, another registry and/or a portable memory device (e.g., an SD memory card) and to transmit that data to the patient history database 5k for storage.
  • the network module 5d may be configured to receive patient information from one or more physician control devices and/or one or more physician support devices located in a specified geographical region (e.g., the northeastern United States, the southeastern United States, the United States, North America, Europe, Japan, China, etc.).
  • the network module 5d is configured to retrieve patient information from the patient history database 5k and to transmit the patient information to a a vestibular stimulation device, a patient control device, a physician control device, a physician support device, another registry and/or a portable memory device (e.g., an SD memory card).
  • the network module 5d may be configured to transmit patient information from the patient history database 5k to one or more physician control devices and/or one or more physician support devices located in a specified geographical region (e.g. , the northeastern United States, the southeastern United States, the United States, North America, Europe, Japan, China, etc.).
  • the present invention provides a telemedicine module for facilitating and/or controlling communications between vestibular stimulation devices, patient control devices, physician control devices, physician support devices and/or registries.
  • the telemedicine module is configured to facilitate and/or control communications between a vestibular stimulation device, a patient control device, a physician control device, a physician support device and/or a registry by ensuring that data is transmitted between the devices in a manner that complies with any and all applicable laws and/or regulations (e.g., the Health Insurance Portability and Accountability Act of 1996 (P.L. 104-191; "HIPAA”)).
  • HIPAA Health Insurance Portability and Accountability Act
  • the telemedicine module may facilitate and/or control communications sent over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the present invention provides a vestibular stimulation system for delivering one or more thermal waveforms (e.g., one or more actively controlled, time-varying thermal waveforms) to the vestibular system and/or the nervous system of a patient.
  • one or more thermal waveforms e.g., one or more actively controlled, time-varying thermal waveforms
  • the vestibular stimulation system may comprise, consist essentially of or consist of a vestibular stimulation device and a physician control device (as shown in Figures 33, 35-36, 38-39, 41 ⁇ 2 and 44).
  • the vestibular stimulation system comprises, consists essentially of or consists of a physician control device and a plurality of vestibular stimulation devices (as shown in Figures 34, 37 and 40).
  • the vestibular stimulation system comprises a plurality of physician control devices and a plurality of vestibular stimulation devices 1 (as shown in Figure 40 and 43). Any suitable vestibular stimulation device(s) and physician control device(s) may be used, including, but not limited to, those described above.
  • the vestibular stimulation system may further comprise a patient control device (as shown in Figures 36 and 38).
  • the vestibular stimulation system comprises a plurality of patient control devices (as shown in Figure 37). Any suitable patient control device(s) may be used, including, but not limited to, those described above.
  • the vestibular stimulation system may further comprise a physician support device (as shown in Figures
  • the vestibular stimulation system comprises a plurality of physician support devices. Any suitable physician support device(s) may be used, including, but not limited to, those described above.
  • the vestibular stimulation system may further comprise a registry (as shown in Figures 42—44).
  • the vestibular stimulation system comprises a plurality of registries. Any suitable registry (or registries) may be used, including, but not limited to, those described above.
  • the vestibular stimulation system may comprise, consist essentially of or consist of a vestibular stimulation device 1 operatively connected to a physician control device 2.
  • the physician control device 2 may be configured to generate one or more thermal waveforms (i.e., to generate the parameters, indications and/or approvals of one or more thermal waveforms) and/or to store the thermal waveform(s) in a database (e.g., to store the parameters, indications and/or approvals of the thermal waveform(s) in a waveform database as described above).
  • the physician control device 2 may be configured to generate one or more prescriptions.
  • Each prescription may comprise, consist essentially of or consist of a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • the prescription may comprise a set of instructions for delivering one or more of the thermal waveforms generated by the physician control device 2 to the vestibular system and/or the nervous system of a patient.
  • the physician control device 2 may be configured to store one or more prescriptions in a database residing therein (e.g., a prescription database as described above) and/or to relay one or more prescriptions to the vestibular stimulation device 1.
  • the physician control device 2 may be configured to transmit one or more prescriptions to the vestibular stimulation device 1 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the vestibular stimulation device 1 may be configured to access a prescription database residing in the physician control device 2 and to retrieve one or more prescriptions using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • one or more prescriptions may be transferred to the vestibular stimulation device 1 using a portable memory device, such as an SD memory card or a USB memory stick.
  • the vestibular stimulation device 1 may be configured to deliver one or more prescribed thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • the vestibular stimulation device 1 may be configured to deliver the prescribed thermal waveform(s) the vestibular system and/or the nervous system of the patient by activating one or more TEDs to warm and/or cool an earpiece inserted into an ear canal of the patient.
  • the vestibular stimulation device 1 may be configured to generate feedback data.
  • the vestibular stimulation device 1 may comprise one or more sensors as described above, which may generate feedback data responsive to delivering the prescribed thermal waveform(s) to the vestibular system and/or the nervous system of the patient.
  • the vestibular stimulation device 1 may comprise a GUI configured generate feedback data (e.g. , patient feedback data) responsive to user input.
  • the vestibular stimulation device 1 may be configured to store feedback data in a database residing therein (e.g. , a feedback database as described above) and/or to relay feedback data to the physician control device 2.
  • the vestibular stimulation device 1 may be configured to transmit feedback data to the physician control device 2 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the physician control device 2 may be configured to access a feedback database residing in the vestibular stimulation device 1 and to retrieve feedback data using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • feedback data may be transferred to the physician control device 2 using a portable memory device, such as an SD memory card or a USB memory stick.
  • the physician control device 2 may be configured to analyze feedback data received and/or retrieved from the vestibular stimulation device 1. For example, the physician control device 2 may be configured to use the feedback data to estimate the thermal contact between one or more earpiece and the patient's ear canal(s), to calculate patient-specific time constants, to evaluate the precision with the prescribed thermal waveform(s) was/were delivered, etc.
  • the physician control device 2 may be configured to modify one or more thermal waveforms responsive to analyzing feedback data received and/or retrieved from the vestibular stimulation device 1.
  • the physician control device 2 may be configured to modify one or more parameters of a thermal waveform generated by the physician control device 2 and/or stored in a waveform database residing therein.
  • the physician control device 2 may be configured to modify the thermal waveform(s) automatically (e.g., the physician control device 2 may be configured to automatically modify one or more thermal waveforms if/when any of its analyses indicate that such modifications are likely to improve the efficacy of the thermal waveform(s)) or responsive to user input.
  • the physician control device 2 may be configured to store one or more modified thermal waveforms in a database residing therein (e.g., a waveform database as described above) and/or to relay the modified thermal waveform(s) to the vestibular stimulation device 1.
  • the physician control device 2 may be configured to transmit one or more modified thermal waveforms to the vestibular stimulation device 1 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the vestibular stimulation device 1 may be configured to access a waveform database residing in the physician control device 2 and to retrieve the modified thermal waveform(s) using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the modified thermal waveform(s) may be transferred to the vestibular stimulation device 1 using a portable memory device, such as an SD memory card or a USB memory stick.
  • the physician control device 2 may be configured to modify one or more prescriptions responsive to analyzing feedback data received and/or retrieved from the vestibular stimulation device 1.
  • the physician control device 2 may be configured to modify one or more parameters of a prescription generated by the physician control device 2 and/or stored in a prescription database residing therein.
  • the physician control device 2 may be configured to modify the prescription(s) automatically (e.g., the physician control device 2 may be configured to automatically modify one or more prescriptions if/when any of its analyses indicate that such modifications are likely to improve the efficacy of the prescription(s)) or responsive to user input.
  • the physician control device 2 may be configured to store one or more modified prescriptions in a database residing therein (e.g., a waveform database as described above) and/or to relay the modified thermal waveform(s) to the vestibular stimulation device 1.
  • the physician control device 2 may be configured to transmit one or more modified prescriptions to the vestibular stimulation device 1 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the vestibular stimulation device 1 may be configured to access a prescription database residing in the physician control device 2 and to retrieve the modified prescription(s) using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the modified prescription(s) may be transferred to the vestibular stimulation device 1 using a portable memory device, such as an SD memory card or a USB memory stick.
  • the vestibular stimulation device 1 may be configured to deliver one or more thermal waveforms to the vestibular system and/or the nervous system of the patient in accordance with one or more modified prescriptions to the vestibular system and/or the nervous system of a patient.
  • the vestibular stimulation device 1 may be configured to deliver the prescribed thermal waveform(s) the vestibular system and/or the nervous system of the patient by activating one or more TEDs to warm and/or cool an earpiece inserted into an ear canal of the patient.
  • the physician control device 2 may be configured to generate one or more software updates.
  • Each software update may comprise, consist essentially of or consist of a set of instructions for modifying one or more operational parameters of the vestibular stimulation device 1.
  • the physician control device 2 may be configured to store one or more software updates in a database residing therein and or to relay one or more software updates to the vestibular stimulation device 1.
  • the physician control device 2 may be configured to transmit one or more software updates to the vestibular stimulation device 1 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the vestibular stimulation device 1 may be configured to access a database residing in the physician control device 2 and to retrieve one or more software updates using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • one or more software updates may be transferred to the vestibular stimulation device 1 using a portable memory device, such as an SD memory card or a USB memory stick.
  • the software update(s) may be relayed from the physician control device 2 to the vestibular stimulation device 1 automatically (e.g. , upon generation, once per week, once per month, etc.) or in response to user input.
  • the vestibular stimulation device 1 may be configured to modify one or more of its operational parameters responsive to receiving and/or retrieving one or more software updates from the physician control device 2.
  • the vestibular stimulation device 1 may be configured to modify one or more of its operational parameters automatically ((e.g., upon receipt of the software update(s), once per week, once per month, etc.) or in response to user input.
  • the vestibular stimulation system may comprise, consist essentially of or consist of a physician control device 2 operatively connected to a plurality of vestibular stimulation devices la, lb, lc, Id.
  • the physician control device 2 may be configured to generate one or more thermal waveforms (i.e., to generate the parameters, indications and/or approvals of one or more thermal waveforms) and/or to store the thermal waveform(s) in a database (e.g., to store the parameters, indications and/or approvals of the thermal waveform(s) in a waveform database as described above).
  • the physician control device 2 may be configured to generate a plurality of prescriptions, each comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • one or more of the prescriptions may comprise a set of instructions for delivering one or more of the thermal waveforms generated by the physician control device 2 to the vestibular system and/or the nervous system of a patient.
  • the physician control device 2 may be configured to store the prescriptions in a database residing therein
  • the physician control device 2 may be configured to transmit the prescriptions to the vestibular stimulation devices la, lb, lc, Id over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • each of the vestibular stimulation devices la, lb, lc, Id may be configured to access a prescription database residing in the physician control device 2 and to retrieve the prescriptions using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the prescriptions may be transferred to the vestibular stimulation devices la, lb, lc, Id using one or more portable memory devices, such as SD memory cards and/or USB memory sticks.
  • Each of the vestibular stimulation devices la, lb, lc, Id may be configured to deliver one or more prescribed thermal waveforms to the vestibular system and/or the nervous system of the patient for whom the prescription was generated.
  • each vestibular stimulation device la, lb, lc, Id may be configured to deliver the prescribed thermal waveform(s) the vestibular system and/or the nervous system of the patient by activating one or more TEDs to warm and/or cool an earpiece inserted into an ear canal of the patient.
  • Each of the vestibular stimulation devices la, lb, lc, Id may be configured to generate feedback data.
  • the vestibular stimulation devices la, lb, lc, Id may comprise one or more sensors as described above, which may generate feedback data responsive to delivering the prescribed thermal waveform(s) to the vestibular system and/or the nervous system of the patient.
  • the vestibular stimulation devices la, lb, lc, Id may comprise a GUI configured generate feedback data (e.g., patient feedback data) responsive to user input.
  • Each of the vestibular stimulation devices la, lb, lc, Id may be configured to store feedback data in a database residing therein (e.g., a feedback database as described above) and/or to relay feedback data to the physician control device 2.
  • the vestibular stimulation devices la, lb, lc, Id may be configured to transmit feedback data to the physician control device 2over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the physician control device 2 may be configured to access one or more feedback databases residing in the vestibular stimulation devices la, lb, lc, Id and to retrieve feedback data using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • feedback data may be transferred to the physician control device 2 using a portable memory device, such as an SD memory card or a USB memory stick.
  • the physician control device 2 may be configured to analyze feedback data received and/or retrieved from one or more of the vestibular stimulation devices la, lb, lc, Id. For example, the physician control device 2 may be configured to use the feedback data to estimate the thermal contact between one or more earpiece and the patient's ear canal(s), to calculate patient-specific time constants, to evaluate the precision with the prescribed thermal waveform(s) was/were delivered, etc.
  • the physician control device 2 may be configured to modify one or more thermal waveforms responsive to analyzing feedback data received and/or retrieved from one or more of the vestibular stimulation devices la, lb, lc, Id.
  • the physician control device 2 may be configured to modify one or more parameters of a thermal waveform generated by the physician control device 2 and/or stored in a waveform database residing therein.
  • the physician control device 2 may be configured to modify the thermal waveform(s) automatically (e.g. , the physician control device 2 may be configured to automatically modify one or more thermal waveforms if/when any of its analyses indicate that such modifications are likely to improve the efficacy of the thermal waveform(s)) or responsive to user input.
  • the physician control device 2 may be configured to store one or more modified thermal waveforms in a database residing therein (e.g., a waveform database as described above) and/or to relay the modified thermal waveform(s) to one or more of the vestibular stimulation devices la, lb, lc, Id.
  • the physician control device 2 may be configured to transmit the modified thermal waveforms to the vestibular stimulation devices la, lb, lc, Id over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • each of the vestibular stimulation devices la, lb, lc, Id may be configured to access a waveform database residing in the physician control device 2 and to retrieve the modified thermal waveform(s) using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the modified thermal waveform(s) may be transferred to one or more of the vestibular stimulation devices la, lb, lc, Id using a portable memory device, such as an SD memory card or a USB memory stick.
  • the physician control device 2 may be configured to modify one or more prescriptions responsive to analyzing feedback data received and/or retrieved from one or more of the vestibular stimulation devices la, lb, lc, Id.
  • the physician control device 2 may be configured to modify one or more parameters of a prescription generated by the physician control device 2 and/or stored in a prescription database residing therein.
  • the physician control device 2 may be configured to modify the prescription(s) automatically (e.g., the physician control device 2 may be configured to automatically modify one or more prescriptions if/when any of its analyses indicate that such modifications are likely to improve the efficacy of the prescription(s)) or responsive to user input.
  • the physician control device 2 may be configured to store one or more modified prescriptions in a database residing therein (e.g., a waveform database as described above) and/or to relay each of the modified prescription(s) to the vestibular stimulation device la, lb, lc, Id associated with the patient for whom the modified prescription(s) was/were generated.
  • the physician control device 2 may be configured to transmit the modified prescription(s) to the vestibular stimulation devices la, lb, lc, Id over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • each of the vestibular stimulation devices la, lb, lc, Id may be configured to access a prescription database residing in the physician control device 2 and to retrieve the modified prescription(s) associated with the patient to whom the vestibular stimulation device la, lb, lc, Id is associated using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the modified prescription(s) may be transferred to the vestibular stimulation devices la, lb, lc, Id using a portable memory device, such as an SD memory card or a USB memory stick.
  • Each of the vestibular stimulation devices la, lb, lc, Id may be configured to deliver one or more thermal waveforms to the vestibular system and/or the nervous system of the patient in accordance with one or more modified prescriptions to the vestibular system and/or the nervous system of a patient.
  • the vestibular stimulation devices la, lb, lc, Id may be configured to deliver the prescribed thermal waveform(s) the vestibular system and/or the nervous system of the patient by activating one or more TEDs to warm and/or cool an earpiece inserted into an ear canal of the patient.
  • the physician control device 2 may be configured to generate one or more software updates.
  • Each software update may comprise, consist essentially of or consist of a set of instructions for modifying one or more operational parameters of the vestibular stimulation devices la, lb, lc, Id.
  • the physician control device 2 may be configured to store one or more software updates in a database residing therein and/or to relay one or more software updates to one or more of the vestibular stimulation devices la, lb, lc, Id.
  • the physician control device 2 may be configured to transmit one or more software updates to the vestibular stimulation devices la, lb, lc, Id over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • each of the vestibular stimulation devices la, lb, lc, Id may be configured to access a database residing in the physician control device 2 and to retrieve one or more software updates using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • one or more software updates may be transferred to the vestibular stimulation devices la, lb, lc, Id using a portable memory device, such as an SD memory card or a USB memory stick.
  • the software update(s) may be relayed from the physician control device 2 to one or more of the vestibular stimulation devices la, lb, lc, Id automatically (e.g. , upon generation, once per week, once per month, etc.) or in response to user input.
  • Each of the vestibular stimulation devices la, lb, lc, Id may be configured to modify one or more of its operational parameters responsive to receiving and/or retrieving one or more software updates from the physician control device 2.
  • the vestibular stimulation devices la, lb, lc, Id may be configured to modify one or more of its operational parameters automatically ((e.g., upon receipt of the software update(s), once per week, once per month, etc.) or in response to user input.
  • the vestibular stimulation system may comprise, consist essentially of or consist of a physician control device 2 operatively connected to a vestibular stimulation device 1 comprising a controller 11, a pair of earpieces 12a, 12b, a pair of TEDs 13a, 13b and a pair of sensors 14a, 14b, wherein each of the TEDs 13a, 13b is operatively connected to the controller 11 via a thermal stimulation lead 16a, 16b and thermally connected to one of the earpieces 12a, 12b and wherein each of the sensors 14a, 14b is operatively connected to the controller 11 via a wireless connection 17a, 17b and thermally connected to one of the earpieces 12a, 12b.
  • the physician control device 2 comprises a waveform module 2a, a treatment module 2b, a network module 2d, a feedback module 2f, a waveform database 2h, a prescription database 2i and a feedback database 2j
  • the controller comprises a control module 11c, a network module lid, a feedback module llf, a prescription database Hi and a feedback database llj.
  • the waveform module 2a may be configured to generate one or more thermal waveforms (i.e., to generate the parameters, indications and/or approvals of one or more thermal waveforms).
  • the physician control device 2 may be configured such that the thermal waveforms generated by the waveform module 2a are transmitted directly to the treatment module 2b and/or are stored in the waveform database 2h, from whence they may subsequently be transmitted to and/or retrieved by the treatment module 2b.
  • the treatment module 2b may be configured to retrieve the thermal waveforms generated by the waveform module 2a from the waveform database 2h.
  • the treatment module 2b may be configured to generate a prescription comprising a set of instructions for delivering one or more of the thermal waveforms generated by the waveform module 2a to the vestibular system and/or the nervous system of a patient.
  • the physician control device 2 may be configured such that the prescription generated by the treatment module 2b is transmitted directly to the vestibular stimulation device 1 by the network module 2d residing in the physician control device 2 and/or is stored in the prescription database 2i residing in the physician control device 2, from whence it may subsequently be transmitted to and/or retrieved by the vestibular stimulation device 1.
  • the network module lid residing in the controller 11 may be configured to receive and/or retrieve the prescription from the physician control device 2 and to relay the prescription to the control module 11c and/or to the prescription database Hi residing in the controller 11.
  • the control module 11c may be configured to retrieve the prescription from the prescription database Hi residing in the controller 11.
  • the control module 11c may be configured to deliver the prescribed thermal waveform(s) by activating the TEDs 13a, 13b in accordance with the prescription (i.e., by activating the TEDs 13a, 13b to by warm and/or cool the earpieces 12a, 12b so as to deliver the prescribed thermal waveform(s)).
  • the feedback module llf residing in the controller 11 may be configured to receive feedback data from the
  • the controller 11 may be configured such that the feedback data received by the feedback module llf is transmitted directly to the physician control device 2 by the network module lid residing in the controller 11 and/or is stored in the feedback database llj residing in the controller 11, from whence it may subsequently be transmitted to and/or retrieved by the physician control device 2.
  • the network module 2d residing in the physician control device 2 may be configured to receive and/or retrieve feedback data from the vestibular stimulation device 1 and to relay the feedback data to the feedback module 2f residing in the physician control device 2 and/or to the feedback database 2j residing in the physician control device 2, from whence it may subsequently be transmitted to and/or retrieved by the feedback module 2f.
  • the feedback module 2f residing in the physician control device 2 may be configured to retrieve feedback data from the feedback database 2j residing in the physician control device 2.
  • the feedback module 2f residing in the physician control device 2 may be configured to analyze the feedback data (e.g., to estimate the thermal contact between each of the earpieces 12a, 12b and the patient's ear canals, to calculate patient-specific time constants, to evaluate the precision with the prescribed thermal waveform(s) was delivered, etc.).
  • the physician control device 2 may be configured such that data associated with the feedback module's 2f analysis are transmitted directly to the waveform module 2a and/or the treatment module 2b and/or are stored in the feedback database 2j, from whence they may subsequently be transmitted to and/or retrieved by the waveform module 2a and/or the treatment module 2b.
  • the waveform module 2a may be configured to retrieve data associated with the feedback module's 2f analysis from the feedback database 2j residing in the physician control device 2.
  • the waveform module 2a may be configured to modify one or more of the thermal waveforms responsive to receiving and/or retrieving data associated with the feedback module's 2f analysis.
  • the waveform module 2a may be configured to modify the thermal waveform(s) automatically (e.g., the waveform module 2a may be configured to periodically check the feedback database 2j for new analyses and to automatically modify one or more thermal waveforms if/when any analysis performed by the feedback module 2f indicates that such modifications are likely to improve the efficacy of the thermal waveform(s)) or responsive to user input.
  • the physician control device 2 may be configured such that any modifications made by the waveform module 2a are relayed to the treatment module 2b as described above.
  • the treatment module 2b may be configured to retrieve data associated with the feedback module's 2f analysis from the feedback database 2j residing in the physician control device 2.
  • the treatment module 2b may be configured to modify, update and/or extend the prescription responsive to receiving and/or retrieving data associated with the feedback module's 2f analysis and/or to receiving and/or retrieving any modifications made by the waveform module 2a.
  • the treatment module 2b may be configured to modify, update and/or extend the prescription automatically (e.g., the treatment module 2b may be configured to periodically check the waveform database 2h for updates and to automatically modify the prescription if/when one or more of the parameters, indications or approvals of a thermal waveform used in the prescription has been modified by the waveform module 2a) or responsive to user input.
  • the physician control device 2 may be configured such that any modifications made by the treatment module 2b are relayed to the vestibular stimulation device 1 as described above.
  • the vestibular stimulation system may comprise, consist essentially of or consist of a vestibular stimulation device 1 operatively connected to a patient control device 3 that is operatively connected to a physician control device 2.
  • the vestibular stimulation device 1 is also operatively connected to the physician control device 2 via an independent operative connection (i.e., independent of the patient control device 3).
  • the physician control device 2 may be configured to generate one or more thermal waveforms (i.e. , to generate the parameters, indications and/or approvals of one or more thermal waveforms) and/or to store the thermal waveform(s) in a database (e.g., to store the parameters, indications and/or approvals of the thermal waveform(s) in a waveform database as described above).
  • the physician control device 2 may be configured to generate one or more prescriptions.
  • Each prescription may comprise, consist essentially of or consist of a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • the prescription may comprise a set of instructions for delivering one or more of the thermal waveforms generated by the physician control device 2 to the vestibular system and/or the nervous system of a patient.
  • the physician control device 2 may be configured to store one or more prescriptions in a database residing therein (e.g., a prescription database as described above) and/or relay one or more prescriptions to the vestibular stimulation device 1 and/or the patient control device 3.
  • the physician control device 2 may be configured to transmit one or more prescriptions to the vestibular stimulation device 1 and/or the patient control device 3 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the vestibular stimulation device 1 and/or the patient control device 3 may be configured to access a prescription database residing in the physician control device 2 and to retrieve one or more prescriptions using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • a portable memory device such as an SD memory card or a USB memory stick.
  • the patient control device 3 may be configured to store one or more prescriptions in a database residing therein (e.g., a prescription database as described above) and/or relay one or more prescriptions to the vestibular stimulation device 1.
  • the patient control device 3 may be configured to transmit one or more prescriptions to the vestibular stimulation device 1 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the vestibular stimulation device 1 may be configured to access a prescription database residing in the patient control device 3 and to retrieve one or more prescriptions using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • one or more prescriptions may be transferred to the vestibular stimulation device 1 using a portable memory device, such as an SD memory card or a USB memory stick.
  • the vestibular stimulation device 1 may be configured to deliver one or more prescribed thermal waveform(s) to the vestibular system and/or the nervous system of a patient.
  • the vestibular stimulation device 1 may be configured to deliver the prescribed thermal waveform(s) the vestibular system and/or the nervous system of the patient by activating one or more TEDs to warm and/or cool an earpiece inserted into an ear canal of the patient.
  • the vestibular stimulation device 1 may be configured to generate feedback data.
  • the vestibular stimulation device 1 may comprise one or more sensors as described above, which may generate feedback data responsive to delivering the prescribed thermal waveform(s) to the vestibular system and/or the nervous system of the patient.
  • the vestibular stimulation device 1 may comprise a GUI configured generate feedback data (e.g., patient feedback data) responsive to user input.
  • the vestibular stimulation device 1 may be configured to store feedback data in a database residing therein (e.g. , a feedback database as described above) and/or to relay feedback data to the patient control device 3 and/or the physician control device 2.
  • the vestibular stimulation device 1 may be configured to transmit feedback data to the patient control device 3 and/or the physician control device 2 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the patient control device 3 and/or the physician control device 2 may be configured to access a feedback database residing in the vestibular stimulation device 1 and to retrieve feedback data using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • feedback data may be transferred to the patient control device 3 and/or the physician control device 2 using a portable memory device, such as an SD memory card or a USB memory stick.
  • the patient control device 3 may be configured to supplement feedback data received and/or retrieved from the vestibular stimulation device 1 with additional feedback data (e.g., patient feedback data).
  • additional feedback data e.g., patient feedback data
  • the patient control device 3 may be configured to store feedback data (including any additional feedback data generated by the patient control device 3) in a database residing therein (e.g. , a feedback database as described above) and/or to relay feedback data (including any additional feedback data generated by the patient control device 3) to the physician control device 2.
  • the patient control device 3 may be configured to transmit feedback data to the physician control device 2 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the physician control device 2 may be configured to access a feedback database residing in the patient control device 3 and to retrieve feedback data using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • feedback data may be transferred to the physician control device 2 using a portable memory device, such as an SD memory card or a USB memory stick.
  • the physician control device 2 may be configured to analyze feedback data received and/or retrieved from the vestibular stimulation device 1 and/or the patient control device 3. For example, the physician control device 2 may be configured to use the feedback data to estimate the thermal contact between one or more earpiece and the patient's ear canal(s), to calculate patient-specific time constants, to evaluate the precision with the prescribed thermal waveform(s) was/were delivered, etc.
  • the physician control device 2 may be configured to modify one or more thermal waveforms responsive to analyzing feedback data received and/or retrieved from the vestibular stimulation device 1 and/or the patient control device 3.
  • the physician control device 2 may be configured to modify one or more parameters of a thermal waveform generated by the physician control device 2 and/or stored in a waveform database residing therein.
  • the physician control device 2 may be configured to modify the thermal waveform(s) automatically (e.g. , the physician control device 2 may be configured to automatically modify one or more thermal waveforms if/when any of its analyses indicate that such modifications are likely to improve the efficacy of the thermal waveform(s)) or responsive to user input.
  • the physician control device 2 may be configured to store one or more modified thermal waveforms in a database residing therein (e.g. , a waveform database as described above) and/or to relay the modified thermal waveform(s) to the vestibular stimulation device 1 and/or the patient control device 3.
  • the physician control device 2 may be configured to transmit the modified thermal waveform(s) to the vestibular stimulation device 1 and/or the patient control device 3 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the vestibular stimulation device 1 and/or the patient control device 3 may be configured to access a waveform database residing in the physician control device 2 and to retrieve the modified thermal waveform(s) using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the modified thermal waveform(s) may be transferred to the vestibular stimulation device 1 and/or the patient control device 3 using a portable memory device, such as an SD memory card or a USB memory stick.
  • the physician control device 2 may be configured to modify one or more prescriptions responsive to analyzing feedback data received and/or retrieved from the vestibular stimulation device 1 and/or the patient control device 3.
  • the physician control device 2 may be configured to modify one or more parameters of a prescription generated by the physician control device 2 and/or stored in a prescription database residing therein.
  • the physician control device 2 may be configured to modify the prescription(s) automatically (e.g., the physician control device 2 may be configured to automatically modify one or more prescriptions if/when any of its analyses indicate that such modifications are likely to improve the efficacy of the prescription(s)) or responsive to user input.
  • the physician control device 2 may be configured to store one or more modified prescriptions in a database residing therein (e.g., a waveform database as described above) and/or to relay the modified thermal waveform(s) to the vestibular stimulation device 1 and/or the patient control device 3.
  • the physician control device 2 may be configured to transmit the modified prescription(s) to the vestibular stimulation device 1 and/or the patient control device 3 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the vestibular stimulation device 1 and/or the patient control device 3 may be configured to access a prescription database residing in the physician control device 2 and to retrieve the modified prescription(s) using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the modified prescription(s) may be transferred to the vestibular stimulation device 1 and/or the patient control device 3 using a portable memory device, such as an SD memory card or a USB memory stick.
  • the patient control device 3 may be configured to store one or more modified prescriptions in a database residing therein (e.g. , a prescription database as described above) and/or transmit one or more modified prescriptions to the vestibular stimulation device 1.
  • the patient control device 3 may be configured to transmit the modified prescription(s) to the vestibular stimulation device 1 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the vestibular stimulation device 1 may be configured to access a prescription database residing in the patient control device 3 and to retrieve one or more modified prescriptions using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • one or more modified prescriptions may be transferred to the vestibular stimulation device 1 using a portable memory device, such as an SD memory card or a USB memory stick.
  • the vestibular stimulation device 1 may be configured to deliver one or more thermal waveforms to the vestibular system and/or the nervous system of the patient in accordance with one or more modified prescriptions to the vestibular system and/or the nervous system of a patient.
  • the vestibular stimulation device 1 may be configured to deliver the prescribed thermal waveform(s) the vestibular system and/or the nervous system of the patient by activating one or more TEDs to warm and/or cool an earpiece inserted into an ear canal of the patient.
  • the physician control device 2 may be configured to generate one or more software updates. Each software update may comprise, consist essentially of or consist of a set of instructions for modifying one or more operational parameters of the vestibular stimulation device 1 and/or the patient control device 3.
  • the physician control device 2 may be configured to store one or more software updates in a database residing therein and/or to relay one or more software updates to the vestibular stimulation device 1 and/or the patient control device 3.
  • the physician control device 2 may be configured to transmit one or more software updates to the vestibular stimulation device 1 and/or the patient control device 3 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the vestibular stimulation device 1 and/or the patient control device 3 may be configured to access a database residing in the physician control device 2 and to retrieve one or more software updates using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • one or more software updates may be transferred to the vestibular stimulation device 1 and/or the patient control device 3 using a portable memory device, such as an SD memory card or a USB memory stick.
  • the software update(s) may be relayed from the physician control device 2 to the vestibular stimulation device 1 and/or the patient control device 3 automatically (e.g., upon generation, once per week, once per month, etc.) or in response to user input.
  • the patient control device 3 may be configured to store one or more software updates in a database residing therein and/or to relay one or more software updates to the vestibular stimulation device 1.
  • the patient control device 3 may be configured to transmit one or more software updates to the vestibular stimulation device 1 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the vestibular stimulation device 1 may be configured to access a database residing in the patient control device 3 and to retrieve one or more software updates using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • one or more software updates may be transferred to the vestibular stimulation device 1 using a portable memory device, such as an SD memory card or a USB memory stick.
  • the software update(s) may be relayed from the patient control device 3 to the vestibular stimulation device 1 automatically (e.g., upon generation, once per week, once per month, etc.) or in response to user input.
  • the patient control device 3 may be configured to modify one or more of its operational parameters responsive to receiving and/or retrieving one or more software updates from the physician control device 2.
  • the patient control device 3 may be configured to modify one or more of its operational parameters automatically ((e.g., upon receipt of the software update(s), once per week, once per month, etc.) or in response to user input.
  • the vestibular stimulation device 1 may be configured to modify one or more of its operational parameters responsive to receiving and/or retrieving one or more software updates from the physician control device 2 and/or the patient control device 3.
  • the vestibular stimulation device 1 may be configured to modify one or more of its operational parameters automatically ((e.g., upon receipt of the software update(s), once per week, once per month, etc.) or in response to user input.
  • the vestibular stimulation system may comprise, consist essentially of or consist of a physician control device 2 operatively connected to a plurality of patient control devices 3a, 3b, 3c, 3d, wherein each of said plurality of patient control devices 3a, 3b, 3c, 3d is operatively connected to one of a plurality of vestibular stimulation devices la, lb, lc, Id.
  • one or more of the vestibular stimulation devices la, lb, lc, Id is also operatively connected to the physician control device 2 via an independent operative connection (i.e., independent of the patient control device 3a, 3b, 3c, 3d with which it is associated).
  • the physician control device 2 may be configured to generate one or more thermal waveforms (i.e., to generate the parameters, indications and/or approvals of one or more thermal waveforms) and/or to store the thermal waveform(s) in a database (e.g., to store the parameters, indications and/or approvals of the thermal waveform(s) in a waveform database as described above).
  • the physician control device 2 may be configured to generate a plurality of prescriptions, each comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • one or more of the prescriptions may comprise a set of instructions for delivering one or more of the thermal waveforms generated by the physician control device 2 to the vestibular system and/or the nervous system of a patient.
  • the physician control device 2 may be configured to store the prescriptions in a database residing therein (e.g., a prescription database as described above) and/or to relay each prescription to a vestibular stimulation device la, lb, lc, Id and/or a patient control device 3a, 3b, 3c, 3d associated with the patient for whom the prescription was generated.
  • the physician control device 2 may be configured to transmit the prescriptions to the vestibular stimulation devices la, lb, lc, Id and/or a patient control devices 3a, 3b, 3c, 3d over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • each of the vestibular stimulation devices la, lb, lc, Id and/or each of the patient control devices 3a, 3b, 3c, 3d may be configured to access a prescription database residing in the physician control device 2 and to retrieve the prescriptions using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the prescriptions may be transferred to the vestibular stimulation devices la, lb, lc, Id and/or the patient control devices 3a, 3b, 3c, 3d using one or more portable memory devices, such as SD memory cards and/or USB memory sticks.
  • Each of the patient control devices 3a, 3b, 3c, 3d may be configured to store one or more prescriptions in a database residing therein (e.g., a prescription database as described above) and/or transmit one or more prescriptions to the vestibular stimulation device la, lb, lc, Id with which it is associated.
  • the patient control devices 3a, 3b, 3c, 3d may be configured to transmit the prescription(s) to the vestibular stimulation device la, lb, lc, Id with which it is associated over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • each of the vestibular stimulation devices la, lb, lc, Id may be configured to access a prescription database residing in the patient control device 3a, 3b, 3c, 3d with which it is associated and to retrieve one or more prescriptions using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • a portable memory device such as an SD memory card or a USB memory stick.
  • Each of the vestibular stimulation devices la, lb, lc, Id may be configured to deliver one or more prescribed thermal waveforms to the vestibular system and/or the nervous system of the patient for whom the prescription was generated.
  • each vestibular stimulation device la, lb, lc, Id may be configured to deliver the prescribed thermal waveform(s) the vestibular system and/or the nervous system of the patient by activating one or more TEDs to warm and/or cool an earpiece inserted into an ear canal of the patient.
  • Each of the vestibular stimulation devices la, lb, lc, Id may be configured to generate feedback data.
  • the vestibular stimulation devices la, lb, lc, Id may comprise one or more sensors as described above, which may generate feedback data responsive to delivering the prescribed thermal waveform(s) to the vestibular system and/or the nervous system of the patient.
  • the vestibular stimulation devices la, lb, lc, Id may comprise a GUI configured generate feedback data (e.g. , patient feedback data) responsive to user input.
  • Each of the vestibular stimulation devices la, lb, lc, Id may be configured to store feedback data in a database residing therein (e.g.
  • the vestibular stimulation devices la, lb, lc, Id may be configured to transmit feedback data to the patient control device 3a, 3b, 3c, 3d with which it is associated and/or to the physician control device 2over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • each of the patient control devices 3a, 3b, 3c, 3d and/or to the physician control device 2 may be configured to access one or more feedback databases residing in the vestibular stimulation devices la, lb, lc, Id and to retrieve feedback data using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • feedback data may be transferred to the patient control devices 3a, 3b, 3c, 3d and/or the physician control device 2 using a portable memory device, such as an SD memory card or a USB memory stick.
  • Each of the patient control devices 3a, 3b, 3c, 3d may be configured to supplement feedback data received and/or retrieved from the vestibular stimulation device la, lb, lc, Id with which it is associated with additional feedback data (e.g. , patient feedback data).
  • additional feedback data e.g. , patient feedback data
  • Each of the patient control devices 3a, 3b, 3c, 3d may be configured to store feedback data (including any additional feedback data generated by the patient control device 3) in a database residing therein (e.g., a feedback database as described above) and/or to relay feedback data (including any additional feedback data generated by the patient control device 3) to the physician control device 2.
  • the patient control devices 3a, 3b, 3c, 3d may be configured to transmit feedback data to the physician control device 2 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the physician control device 2 may be configured to access one or more feedback databases residing in the patient control devices 3a, 3b, 3c, 3d and to retrieve feedback data using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • feedback data may be transferred to the physician control device 2 using a portable memory device, such as an SD memory card or a USB memory stick.
  • the physician control device 2 may be configured to analyze feedback data received and/or retrieved from one or more of the vestibular stimulation devices la, lb, lc, Id and/or one or more of the patient control devices 3a, 3b, 3c, 3d. For example, the physician control device 2 may be configured to use the feedback data to estimate the thermal contact between one or more earpiece and the patient's ear canal(s), to calculate patient-specific time constants, to evaluate the precision with the prescribed thermal waveform(s) was/were delivered, etc.
  • the physician control device 2 may be configured to modify one or more thermal waveforms responsive to analyzing feedback data received and/or retrieved from one or more of the vestibular stimulation devices la, lb, lc, Id and/or one or more of the patient control devices 3a, 3b, 3c, 3d.
  • the physician control device 2 may be configured to modify one or more parameters of a thermal waveform generated by the physician control device 2 and/or stored in a waveform database residing therein.
  • the physician control device 2 may be configured to modify the thermal waveform(s) automatically (e.g., the physician control device 2 may be configured to automatically modify one or more thermal waveforms if/when any of its analyses indicate that such modifications are likely to improve the efficacy of the thermal waveform(s)) or responsive to user input.
  • the physician control device 2 may be configured to store one or more modified thermal waveforms in a database residing therein (e.g., a waveform database as described above) and/or to relay the modified thermal waveform(s) to one or more of the vestibular stimulation devices la, lb, lc, Id and/or one or more of the patient control devices 3a, 3b, 3c, 3d.
  • a database residing therein (e.g., a waveform database as described above) and/or to relay the modified thermal waveform(s) to one or more of the vestibular stimulation devices la, lb, lc, Id and/or one or more of the patient control devices 3a, 3b, 3c, 3d.
  • the physician control device 2 may be configured to transmit the modified thermal waveform(s) to one or more of the vestibular stimulation devices la, lb, lc, Id and/or one or more of the patient control devices 3a, 3b, 3c, 3d over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • one or more of the vestibular stimulation devices la, lb, lc, Id and/or one or more of the patient control devices 3a, 3b, 3c, 3d may be configured to access a waveform database residing in the physician control device 2 and to retrieve the modified thermal waveform(s) using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the modified thermal waveform(s) may be transferred to one or more of the vestibular stimulation devices la, lb, lc, Id and/or one or more of the patient control devices 3a, 3b, 3c, 3d using a portable memory device, such as an SD memory card or a USB memory stick.
  • a portable memory device such as an SD memory card or a USB memory stick.
  • the physician control device 2 may be configured to modify one or more prescriptions responsive to analyzing feedback data received and/or retrieved from one or more of the vestibular stimulation devices la, lb, lc, Id and/or one or more of the patient control devices 3a, 3b, 3c, 3d.
  • the physician control device 2 may be configured to modify one or more parameters of a prescription generated by the physician control device 2 and/or stored in a prescription database residing therein.
  • the physician control device 2 may be configured to modify the prescription(s) automatically (e.g., the physician control device 2 may be configured to automatically modify one or more prescriptions if/when any of its analyses indicate that such modifications are likely to improve the efficacy of the prescription(s)) or responsive to user input.
  • the physician control device 2 may be configured to store one or more modified prescriptions in a database residing therein (e.g. , a waveform database as described above) and/or to relay each of the modified prescription(s) to the vestibular stimulation devices la, lb, lc, Id and/or one or more of the patient control devices 3a, 3b, 3c, 3d associated with the patient for whom the prescription was generated.
  • a database residing therein (e.g. , a waveform database as described above) and/or to relay each of the modified prescription(s) to the vestibular stimulation devices la, lb, lc, Id and/or one or more of the patient control devices 3a, 3b, 3c, 3d associated with the patient for whom the prescription was generated.
  • the physician control device 2 may be configured to transmit the modified prescription(s) to the vestibular stimulation devices la, lb, lc, Id and/or the patient control devices 3a, 3b, 3c, 3d over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • each of the vestibular stimulation devices la, lb, lc, Id and/or each of the patient control devices 3a, 3b, 3c, 3d may be configured to access a prescription database residing in the physician control device 2 and to retrieve the modified prescription(s) associated with the patient to whom the vestibular stimulation device la, lb, lc, Id and/or the patient control device 3a, 3b, 3c, 3d is associated using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the modified prescription(s) may be transferred to the vestibular stimulation devices la, lb, lc, Id and/or the patient control devices 3a, 3b, 3c, 3d using a portable memory device, such as an SD memory card or a USB memory stick.
  • a portable memory device such as an SD memory card or a USB memory stick.
  • Each of the patient control devices 3a, 3b, 3c, 3d may be configured to store one or more modified prescriptions in a database residing therein (e.g., a prescription database as described above) and/or transmit one or more prescriptions to the vestibular stimulation device la, lb, lc, Id with which it is associated.
  • the patient control devices 3a, 3b, 3c, 3d may be configured to transmit the modified prescription(s) to the vestibular stimulation device la, lb, lc, Id with which it is associated over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • each of the vestibular stimulation devices la, lb, lc, Id may be configured to access a prescription database residing in the patient control device 3a, 3b, 3c, 3d with which it is associated and to retrieve one or more modified prescriptions using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • one or more modified prescriptions may be transferred to the vestibular stimulation devices la, lb, lc, Id using a portable memory device, such as an SD memory card or a USB memory stick.
  • the vestibular stimulation devices la, lb, lc, Id may be configured to deliver one or more thermal waveforms to the vestibular system and/or the nervous system of the patient in accordance with one or more modified prescriptions to the vestibular system and/or the nervous system of a patient.
  • the vestibular stimulation devices la, lb, lc, Id may be configured to deliver the prescribed thermal waveform(s) the vestibular system and/or the nervous system of the patient by activating one or more TEDs to warm and/or cool an earpiece inserted into an ear canal of the patient.
  • the physician control device 2 may be configured to generate one or more software updates.
  • Each software update may comprise, consist essentially of or consist of a set of instructions for modifying one or more operational parameters one or more of the vestibular stimulation devices la, lb, lc, Id and/or one or more of the patient control devices 3a, 3b, 3c, 3d.
  • the physician control device 2 may be configured to store one or more software updates in a database residing therein and/or to relay one or more software updates to one or more of the vestibular stimulation devices la, lb, lc, Id and/or one or more of the patient control devices 3a, 3b, 3c, 3d.
  • the physician control device 2 may be configured to transmit one or more software updates to the vestibular stimulation devices la, lb, lc, Id and/or the patient control devices 3a, 3b, 3c, 3d over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • each of the vestibular stimulation devices la, lb, lc, Id and/or each of the patient control devices 3a, 3b, 3c, 3d may be configured to access a database residing in the physician control device 2 and to retrieve one or more software updates using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • one or more software updates may be transferred to the vestibular stimulation devices la, lb, lc, Id and/or the patient control devices 3a, 3b, 3c, 3d using a portable memory device, such as an SD memory card or a USB memory stick.
  • the software update(s) may be relayed from the physician control device 2 to the vestibular stimulation devices la, lb, lc, Id and/or the patient control devices 3a, 3b, 3c, 3d automatically (e.g., upon generation, once per week, once per month, etc.) or in response to user input.
  • Each of the patient control devices 3a, 3b, 3c, 3d may be configured to store one or more software updates in a database residing therein and/or transmit one or more software updates to the vestibular stimulation device la, lb, lc, Id with which it is associated.
  • the patient control devices 3a, 3b, 3c, 3d may be configured to transmit the software update(s) to the vestibular stimulation device la, lb, lc, Id with which it is associated over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • each of the vestibular stimulation devices la, lb, lc, Id may be configured to access a database residing in the patient control device 3a, 3b, 3c, 3d with which it is associated and to retrieve one or more software updates using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • one or more software updates may be transferred to the vestibular stimulation devices la, lb, lc, Id using a portable memory device, such as an SD memory card or a USB memory stick.
  • Each of the patient control devices 3a, 3b, 3c, 3d may be configured to modify one or more of its operational parameters responsive to receiving and/or retrieving one or more software updates from the physician control device 2.
  • the patient control devices 3a, 3b, 3c, 3d may be configured to modify one or more of its operational parameters automatically ((e.g. , upon receipt of the software update(s), once per week, once per month, etc.) or in response to user input.
  • Each of the vestibular stimulation devices la, lb, lc, Id may be configured to modify one or more of its operational parameters responsive to receiving and/or retrieving one or more software updates from the physician control device 2 and/or the patient control device 3a, 3b, 3c, 3d with which it is associated.
  • the vestibular stimulation devices la, lb, lc, Id may be configured to modify one or more of its operational parameters automatically ((e.g., upon receipt of the software update(s), once per week, once per month, etc.) or in response to user input.
  • the vestibular stimulation system comprises, consists essentially of or consists of a physician control device 2 operatively connected to a patient control device 3 that is operatively connected to a vestibular stimulation device 1 comprising a controller 11, an earpiece 12, a TED 13, a pair of sensors 14a, 14b and a heat sink 15, wherein the TED 13 is operatively connected to the controller 11 via a thermal stimulation lead 16 and thermally connected between the earpiece 12 and the heat sink 15, wherein one of the sensors 14a is operatively connected to the controller 11 via a wireless connection 17a and thermally connected to the heat sink 15 and wherein the other sensor 14b is operatively connected to the controller 11 via a wireless connection 17b and thermally connected to the earpiece 12.
  • the physician control device 2 comprises a waveform module 2a, a treatment module 2b, a network module 2d, a feedback module 2f, a waveform database 2h, a prescription database 2i and a feedback database 2j
  • the patient control device 3 comprises a network module 3d, a feedback module 3f, a prescription database 3i and a feedback database 3j
  • the controller comprises a control module 11c, a network module lid and a feedback module llf.
  • the waveform module 2a may be configured to generate one or more thermal waveforms (i.e., to generate the parameters, indications and/or approvals of one or more thermal waveforms).
  • the physician control device may be configured such that the thermal waveforms generated by the waveform module 2a are transmitted directly to the treatment module 2b and/or are stored in the waveform database 2h, from whence they may subsequently be transmitted to and/or retrieved by the treatment module 2b.
  • the treatment module 2b may be configured to retrieve the thermal waveforms generated by the waveform module 2a from the waveform database 2h.
  • the treatment module 2b may be configured to generate a prescription comprising a set of instructions for delivering one or more of the thermal waveforms generated by the waveform module 2a to the vestibular system and/or the nervous system of a patient.
  • the physician control device 2 may be configured such that the prescription generated by the treatment module 2b is transmitted directly to the patient control device 3 by the network module 2d residing in the physician control device 2 and/or is stored in the prescription database 2i residing in the physician control device 2, from whence it may subsequently be transmitted to and/or retrieved by the patient control device 3.
  • the network module lid residing in the patient control device 3 may be configured to receive and/or retrieve the prescription from the physician control device 2 and to relay the prescription to the vestibular stimulation device 1 and/or to the prescription database Hi residing in the patient control device 3.
  • the network module lid residing in the controller 11 may be configured to receive and/or retrieve the prescription from the patient control device 3 and to relay the prescription to the control module 11.
  • the control module 11c may be configured to deliver the prescribed thermal waveform(s) by activating the TED 13 in accordance with the prescription (i.e., by activating the TED 13 to by warm and/or cool the earpiece 12 so as to deliver the prescribed thermal waveform(s)).
  • the feedback module llf residing in the controller 11 may be configured to receive feedback data from the TED 13 and/or the sensors 14a, 14b (e.g., data associated with the temperature of the earpiece 12, the temperature of the patient's ear canals, the temperature of the heat sink 15, etc.).
  • the controller 11 may be configured such that the feedback data received by the feedback module llf is transmitted directly to the patient control device 3 by the network module lid residing in the controller 11.
  • the network module 3d residing in the patient control device 3 may be configured to receive feedback data from the vestibular stimulation device 1 and to relay the feedback data to the physician control device 2 and/or to the feedback database 3j residing in the patient control device 3, from whence it may subsequently be transmitted to and/or retrieved by the physician control device 2.
  • the patient control device 3 may be configured to supplement the feedback data received from the vestibular stimulation device 1 with additional feedback data ⁇ e.g., patient feedback data) and to relay the additional feedback data to the physician control device 2 and/or to the feedback database 3j residing in the patient control device 3, from whence it may subsequently be transmitted to and/or retrieved by the physician control device 2.
  • additional feedback data e.g., patient feedback data
  • the network module 2d residing in the physician control device 2 may be configured to receive and/or retrieve feedback data from the patient control device 3 (including any additional feedback data supplied by the patient control device 3) and to relay the feedback data to the feedback module 2f residing in the physician control device 2 and/or to the feedback database 2j residing in the physician control device 2, from whence it may subsequently be transmitted to and/or retrieved by the feedback module 2f residing in the physician control device 2.
  • the feedback module 2f residing in the physician control device 2 may be configured to retrieve the feedback data from the feedback database 2j residing in the physician control device 2.
  • the feedback module 2f residing in the physician control device 2 may be configured to analyze the feedback data (e.g., to estimate the thermal contact between each of the earpiece 12a and the patient's ear canal, to calculate patient-specific time constants, to evaluate the precision with the prescribed thermal waveform(s) was delivered, etc.).
  • the physician control device 2 may be configured such that data associated with the feedback module's 2f analysis are transmitted directly to the waveform module 2a and/or the treatment module 2b and/or are stored in the feedback database 2j, from whence they may subsequently be transmitted to and/or retrieved by the waveform module 2a and/or the treatment module 2b.
  • the waveform module 2a may be configured to retrieve data associated with the feedback module's 2f analysis from the feedback database 2j residing in the physician control device 2.
  • the waveform module 2a may be configured to modify one or more of the thermal waveforms responsive to receiving and/or retrieving data associated with the feedback module's 2f analysis.
  • the physician control device 2 may be configured such that any modifications made by the waveform module 2a are relayed to the treatment module 2b as described above.
  • the treatment module 2b may be configured to retrieve data associated with the feedback module's 2f analysis from the feedback database 2j residing in the physician control device 2.
  • the treatment module 2b may be configured to modify, update and/or extend the prescription responsive to receiving and/or retrieving data associated with the feedback module's 2f analysis and/or to receiving and/or retrieving any modifications made by the waveform module 2a.
  • the physician control device 2 may be configured such that any modifications made by the treatment module 2b are relayed to the vestibular stimulation device 1 and the patient control device 3 as described above.
  • the vestibular stimulation system may comprise, consist essentially of or consist of a vestibular stimulation device 1 operatively connected to a physician control device 2 that is operatively connected to a physician support device 4.
  • the physician support device 4 may be configured to generate one or more thermal waveforms (i.e., to generate the parameters, indications and/or approvals of one or more thermal waveforms) and/or to store the thermal waveform(s) in a database (e.g., to store the parameters, indications and/or approvals of the thermal waveform(s) in a waveform database as described above).
  • the physician support device 4 may be configured to store one or more thermal waveform(s) in a database residing therein (e.g., a waveform database as described above) and/or relay one or more thermal waveforms to the physician control device 2.
  • the physician support device 4 may be configured to transmit one or more prescriptions to the physician control device 2 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the physician control device 2 may be configured to access a waveform database residing in the physician support device 4 and to retrieve one or more thermal waveform(s) using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • a portable memory device such as an SD memory card or a USB memory stick.
  • the physician control device 2 may be configured to generate one or more prescriptions.
  • Each prescription may comprise, consist essentially of or consist of a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • the prescription may comprise a set of instructions for delivering one or more of the thermal waveforms generated by the physician support device 4 to the vestibular system and/or the nervous system of a patient.
  • the physician control device 2 may be configured to store one or more prescriptions in a database residing therein (e.g. , a prescription database as described above) and/or to relay one or more prescriptions to the vestibular stimulation device 1.
  • the physician control device 2 may be configured to transmit one or more prescriptions to the vestibular stimulation device 1 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the vestibular stimulation device 1 may be configured to access a prescription database residing in the physician control device 2 and to retrieve one or more prescriptions using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • one or more prescriptions may be transferred to the vestibular stimulation device 1 using a portable memory device, such as an SD memory card or a USB memory stick.
  • the vestibular stimulation device 1 may be configured to deliver one or more prescribed thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • the vestibular stimulation device 1 may be configured to deliver the prescribed thermal waveform(s) the vestibular system and/or the nervous system of the patient by activating one or more TEDs to warm and/or cool an earpiece inserted into an ear canal of the patient.
  • the vestibular stimulation device 1 may be configured to generate feedback data.
  • the vestibular stimulation device 1 may comprise one or more sensors as described above, which may generate feedback data responsive to delivering the prescribed thermal waveform(s) to the vestibular system and/or the nervous system of the patient.
  • the vestibular stimulation device 1 may comprise a GUI configured generate feedback data (e.g., patient feedback data) responsive to user input.
  • the vestibular stimulation device 1 may be configured to store feedback data in a database residing therein (e.g. , a feedback database as described above) and/or to relay feedback data to the physician control device 2 and/or the physician support device 4.
  • the vestibular stimulation device 1 may be configured to transmit feedback data to the physician control device 2 and/or the physician support device 4 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the physician control device 2 and/or the physician support device 4 may be configured to access a feedback database residing in the vestibular stimulation device 1 and to retrieve feedback data using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • feedback data may be transferred to the physician control device 2 and/or the physician support device 4 using a portable memory device, such as an SD memory card or a USB memory stick.
  • the physician control device 2 may be configured to supplement feedback data received and/or retrieved from the vestibular stimulation device 1 with additional feedback data (e.g., physician feedback data).
  • additional feedback data e.g., physician feedback data
  • the physician control device 2 may be configured to store feedback data (including any additional feedback data supplied by the physician control device 2) in a database residing therein (e.g., a feedback database as described above) and/or to relay feedback data (including any additional feedback data supplied by the physician control device 2) to the physician support device 4.
  • the physician control device 2 may be configured to transmit feedback data to the physician support device 4 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the physician support device 4 may be configured to access a feedback database residing in the physician control device 2 and to retrieve feedback data using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • feedback data may be transferred to the physician support device 4 using a portable memory device, such as an SD memory card or a USB memory stick.
  • the physician control device 2 may be configured to analyze feedback data received and/or retrieved from the vestibular stimulation device 1. For example, the physician control device 2 may be configured to use the feedback data to estimate the thermal contact between one or more earpiece and the patient's ear canal(s), to calculate patient-specific time constants, to evaluate the precision with the prescribed thermal waveform(s) was/were delivered, etc.
  • the physician support device 4 may be configured to analyze feedback data received and/or retrieved from the vestibular stimulation device 1 and/or the physician control device 2. For example, the physician support device 4 may be configured to use the feedback data to identify waveform characteristics that may be linked to increased/decreased efficacy with regard to the treatment of a given disease/disorder/injury, to identify modifications that are likely to increase the effectiveness of a given thermal waveform, class of thermal waveforms or combination of thermal waveforms; to identify new diseases/disorders/injuries for which a given thermal waveform, class of thermal waveforms, combination of thermal waveforms and/or treatment regimen may provide an effective treatment; to predict which thermal waveform(s) or combination(s) of thermal waveforms may be most effective in treating a given disease/disorder/injury; to identify thermal waveforms, classes of thermal waveforms and/or combinations of thermal waveforms that are not likely to be effective in the treatment of a given disease/disorder/injury, etc.
  • the feedback module is configured to identify new idealized thermal waveforms by identifying one or more diseases/disorders/injuries for which a thermal waveform or class of waveforms is likely to be an effective treatment (e.g., by identifying a new thermal waveform that belongs to a class of waveforms known to be effective in treating one or more diseases/disorders/injuries), to identify one or more additional diseases/disorders/injuries for which a previously identified idealized thermal waveform is likely to be an effective treatment (e.g.
  • one or more co-morbid diseases/disorders/injuries that also appear to be effectively treated by the idealized thermal waveform and/or to identify one or more diseases/disorders/injuries for which a previously identified idealized thermal waveform is not likely to be an effective treatment (e.g., one or more of the diseases/disorders/injuries for which an idealized thermal waveform had previously been indicated and/or approved may be removed from the list of indications for that thermal waveform or for the class of thermal waveforms to which it belongs).
  • the physician support device 4 may be configured to modify one or more thermal waveforms responsive to analyzing feedback data received and/or retrieved from the vestibular stimulation device 1 and/or the physician control device 2.
  • the physician support device 4 may be configured to modify one or more parameters of a thermal waveform generated by the physician support device 4 and/or stored in a waveform database residing therein.
  • the physician support device 4 may be configured to modify the thermal waveform(s) automatically (e.g., the physician support device 4 may be configured to automatically modify one or more thermal waveforms if/when any of its analyses indicate that such modifications are likely to improve the efficacy of the thermal waveform(s)) or responsive to user input.
  • the physician support device 4 may be configured to store one or more modified thermal waveforms in a database residing therein (e.g., a waveform database as described above) and/or to relay the modified thermal waveform(s) to the physician control device 2.
  • the physician support device 4 may be configured to transmit one or more modified thermal waveforms to the physician control device 2 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the physician control device 2 may be configured to access a waveform database residing in the physician support device 4 and to retrieve the modified thermal waveform(s) using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the modified thermal waveform(s) may be transferred to the physician control device 2 using a portable memory device, such as an SD memory card or a USB memory stick.
  • the physician control device 2 may be configured to modify one or more prescriptions responsive to analyzing feedback data received and/or retrieved from the vestibular stimulation device 1 and/or to receiving and/or retrieving one or more modified thermal waveforms from the physician support device 4.
  • the physician control device 2 may be configured to modify one or more parameters of a prescription generated by the physician control device 2 and/or stored in a prescription database residing therein.
  • the physician control device 2 may be configured to modify the prescription(s) automatically (e.g. , the physician control device 2 may be configured to automatically modify one or more prescriptions if/when any of its analyses indicate that such modifications are likely to improve the efficacy of the prescription(s)) or responsive to user input.
  • the physician control device 2 may be configured to store one or more modified prescriptions in a database residing therein (e.g., a waveform database as described above) and/or to relay the modified thermal waveform(s) to the vestibular stimulation device 1.
  • the physician control device 2 may be configured to transmit one or more modified prescriptions to the vestibular stimulation device 1 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the vestibular stimulation device 1 may be configured to access a prescription database residing in the physician control device 2 and to retrieve the modified prescription(s) using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the modified prescription(s) may be transferred to the vestibular stimulation device 1 using a portable memory device, such as an SD memory card or a USB memory stick.
  • the vestibular stimulation device 1 may be configured to deliver one or more thermal waveforms to the vestibular system and/or the nervous system of the patient in accordance with one or more modified prescriptions to the vestibular system and/or the nervous system of a patient.
  • the vestibular stimulation device 1 may be configured to deliver the prescribed thermal waveform(s) the vestibular system and/or the nervous system of the patient by activating one or more TEDs to warm and/or cool an earpiece inserted into an ear canal of the patient.
  • the physician support device 4 may be configured to generate one or more software updates.
  • Each software update may comprise, consist essentially of or consist of a set of instructions for modifying one or more operational parameters of the vestibular stimulation device 1 and/or the physician control device 2.
  • the physician support device 4 may be configured to store one or more software updates in a database residing therein and/or to relay one or more software updates to the vestibular stimulation device 1 and/or the physician control device 2.
  • the physician support device 4 may be configured to transmit one or more software updates to the vestibular stimulation device 1 and/or the physician control device 2 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the vestibular stimulation device 1 and/or the physician control device 2 may be configured to access a database residing in the physician support device 4 and to retrieve one or more software updates using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • one or more software updates may be transferred to the vestibular stimulation device 1 and/or the physician control device 2 using a portable memory device, such as an SD memory card or a USB memory stick.
  • the software update(s) may be relayed from the physician support device 4 to the vestibular stimulation device 1 and/or the physician control device 2 automatically (e.g., upon generation, once per week, once per month, etc.) or in response to user input.
  • the physician control device 2 may be configured to store one or more software updates in a database residing therein and/or to relay one or more software updates to the vestibular stimulation device 1.
  • the physician control device 2 may be configured to transmit one or more software updates to the vestibular stimulation device 1 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the vestibular stimulation device 1 may be configured to access a database residing in the physician control device 2 and to retrieve one or more software updates using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • one or more software updates may be transferred to the vestibular stimulation device 1 using a portable memory device, such as an SD memory card or a USB memory stick.
  • the software update(s) may be relayed from the physician control device 2 to the vestibular stimulation device 1 automatically (e.g., upon generation, once per week, once per month, etc.) or in response to user input.
  • the physician control device 2 may be configured to modify one or more of its operational parameters responsive to receiving and/or retrieving one or more software updates from the physician support device 4.
  • the physician control device 2 may be configured to modify one or more of its operational parameters automatically ((e.g., upon receipt of the software update(s), once per week, once per month, etc.) or in response to user input.
  • the vestibular stimulation device 1 may be configured to modify one or more of its operational parameters responsive to receiving and/or retrieving one or more software updates from the physician support device 4 and/or the physician control device 2.
  • the vestibular stimulation device 1 may be configured to modify one or more of its operational parameters automatically ((e.g., upon receipt of the software update(s), once per week, once per month, etc.) or in response to user input.
  • the vestibular stimulation system comprises, consists essentially of or consists of a physician support device 4 operatively connected to a plurality of physician control devices 2a, 2b wherein each of said plurality of physician control devices 2a, 2b is operatively connected a plurality of vestibular stimulation devices la, lb, lc, Id.
  • one or more of the vestibular stimulation devices la, lb, lc, Id is also operatively connected to the physician supprt device 4 via an independent operative connection (i.e., independent of the physician control device 2a, 2b with which it is associated).
  • the physician support device 4 may be configured to generate one or more thermal waveforms (i.e., to generate the parameters, indications and/or approvals of one or more thermal waveforms) and/or to store the thermal- waveform(s) in a database (e.g., to store the parameters, indications and/or approvals of the thermal waveform(s) in a waveform database as described above).
  • the physician support device 4 may be configured to store one or more thermal waveform(s) in a database residing therein (e.g., a waveform database as described above) and/or relay one or more thermal waveforms to one or more of the physician control devices 2a, 2b.
  • the physician support device 4 may be configured to transmit one or more prescriptions to the physician control devices 2a, 2b over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • each of the physician control devices 2a, 2b may be configured to access a waveform database residing in the physician support device 4 and to retrieve one or more thermal waveform(s) using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • one or more thermal waveform(s) may be transferred to the physician control devices 2a, 2b using a portable memory device, such as an SD memory card or a USB memory stick.
  • Each of the physician control devices 2a, 2b may be configured to generate a plurality of prescriptions, each comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient.
  • one or more of the prescriptions may comprise a set of instructions for delivering one or more of the thermal waveforms generated by the physician support device 4 to the vestibular system and/or the nervous system of a patient.
  • Each of the physician control devices 2a, 2b may be configured to store one or more prescriptions in a database residing therein (e.g., a prescription database as described above) and/or to relay each prescription to a vestibular stimulation device la, lb, lc, Id associated with the patient for whom the prescription was generated.
  • the physician control devices 2a, 2b may be configured to transmit the prescriptions to the vestibular stimulation devices la, lb, lc, Id over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • each of the vestibular stimulation devices la, lb, lc, Id may be configured to access a prescription database residing in the physician control device 2a, 2b with which it is associated and to retrieve the prescriptions using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the prescriptions may be transferred to the vestibular stimulation devices la, lb, lc, Id using one or more portable memory devices, such as SD memory cards and/or USB memory sticks.
  • Each of the vestibular stimulation devices la, lb, lc, Id may be configured to deliver one or more prescribed thermal waveforms to the vestibular system and/or the nervous system of the patient for whom the prescription was generated.
  • each vestibular stimulation device la, lb, lc, Id may be configured to deliver the prescribed thermal waveform(s) the vestibular system and/or the nervous system of the patient by activating one or more TEDs to warm , and/or cool an earpiece inserted into an ear canal of the patient.
  • Each of the vestibular stimulation devices la, lb, lc, Id may be configured to store feedback data in a database residing therein (e.g., a feedback database as described above) and/or to relay feedback data to the physician control device 2a, 2b with which it is associated and/or to the physician support device 4.
  • a database residing therein (e.g., a feedback database as described above)
  • Each of the vestibular stimulation devices la, lb, lc, Id may be configured to transmit feedback data to the physician control device 2a, 2b with which it is associated and/or to the physician support device 4 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • each of the physician control devices 2a, 2b and/or to the physician support device 4 may be configured to access one or more feedback databases residing in the vestibular stimulation devices la, lb, lc, Id and to retrieve feedback data using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • feedback data may be transferred to the physician control devices 2a, 2b and/or to the physician support device 4 using a portable memory device, such as an SD memory card or a USB memory stick.
  • Each of the physician control devices 2a, 2b may be configured to supplement feedback data received and/or retrieved from the vestibular stimulation device la, lb, lc, Id with which it is associated with additional feedback data (e.g. , physician feedback data).
  • additional feedback data e.g. , physician feedback data
  • Each of the physician control devices 2a, 2b may be configured to store feedback data (including any additional feedback data supplied by the physician control devices 2a, 2b) in a database residing therein (e.g., a feedback database as described above) and/or to relay feedback data (including any additional feedback data supplied by the physician control devices 2a, 2b) to the physician support device 4.
  • the physician control devices 2a, 2b 2 may be configured to transmit feedback data to the physician support device 4 over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the physician support device 4 may be configured to access one or more feedback databases residing in the physician control devices 2a, 2b and to retrieve feedback data using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • feedback data may be transferred to the physician support device 4 using a portable memory device, such as an SD memory card or a USB memory stick.
  • Each of the physician control devices 2a, 2b may be configured to analyze feedback data received and/or retrieved from the vestibular stimulation device la, lb, lc, Id with which it is associated.
  • the physician control devices 2a, 2b may be configured to use the feedback data to estimate the thermal contact between one or more earpiece and the patient's ear canal(s), to calculate patient-specific time constants, to evaluate the precision with the prescribed thermal waveform(s) was/were delivered, etc.
  • the physician support device 4 may be configured to analyze feedback data received and/or retrieved from the vestibular stimulation devices la, lb, lc, Id and/or the physician control devices 2a, 2b. For example, the physician support device 4 may be configured to use the feedback data to identify waveform characteristics that may be linked to increased/decreased efficacy with regard to the treatment of a given disease/disorder/injury, to identify modifications that are likely to increase the effectiveness of a given thermal waveform, class of thermal waveforms or combination of thermal waveforms; to identify new diseases/disorders/injuries for which a given thermal waveform, class of thermal waveforms, combination of thermal waveforms and/or treatment regimen may provide an effective treatment; to predict which thermal waveform(s) or combination(s) of thermal waveforms may be most effective in treating a given disease/disorder/injury; to identify thermal waveforms, classes of thermal waveforms and/or combinations of thermal waveforms that are not likely to be effective in the treatment of a
  • the feedback module is configured to identify new idealized thermal waveforms by identifying one or more diseases/disorders/injuries for which a thermal waveform or class of waveforms is likely to be an effective treatment (e.g., by identifying a new thermal waveform that belongs to a class of waveforms known to be effective in treating one or more diseases/disorders/injuries), to identify one or more additional diseases/disorders/injuries for which a previously identified idealized thermal waveform is likely to be an effective treatment (e.g., by identifying, in a population of patients receiving treatment with an idealized thermal waveform for treatment of a first disease/disorder/injury, one or more co-morbid diseases/disorders/injuries that also appear to be effectively treated by the idealized thermal waveform) and/or to identify one or more diseases/disorders/injuries for which a previously identified idealized thermal waveform is not likely to be an effective treatment (e.g., one or more of the
  • the physician support device 4 may be configured to modify one or more thermal waveforms responsive to analyzing feedback data received and/or retrieved from the vestibular stimulation devices la, lb, lc, Id and/or the physician control devices 2a, 2b.
  • the physician support device 4 may be configured to modify one or more parameters of a thermal waveform generated by the physician support device 4 and/or stored in a waveform database residing therein.
  • the physician support device 4 may be configured to modify the thermal waveform(s) automatically (e.g. , the physician support device 4 may be configured to automatically modify one or more thermal waveforms if/when any of its analyses indicate that such modifications are likely to improve the efficacy of the thermal waveform(s)) or responsive to user input.
  • the physician support device 4 may be configured to store one or more modified thermal waveforms in a database residing therein (e.g., a waveform database as described above) and/or to relay the modified thermal waveform(s) to one or more of the physician control devices 2a, 2b.
  • the physician support device 4 may be configured to transmit one or more modified thermal waveforms to one or more of the physician control devices 2a, 2b over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • each of the physician control devices 2a, 2b may be configured to access a waveform database residing in the physician support device 4 and to retrieve the modified thermal waveform(s) using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the modified thermal waveform(s) may be transferred to the physician control devices 2a, 2b using a portable memory device, such as an SD memory card or a USB memory stick.
  • Each of the physician control devices 2a, 2b may be configured to modify one or more prescriptions responsive to analyzing feedback data received and/or retrieved from the vestibular stimulation device la, lb, lc, Id with which it is associated and/or to receiving and/or retrieving one or more modified thermal waveforms from the physician support device 4.
  • the physician control devices 2a, 2b may be configured to modify one or more parameters of a prescription generated by the physician control devices 2a, 2b and/or stored in a prescription database residing therein.
  • the physician control devices 2a, 2b may be configured to modify the prescription(s) automatically (e.g., the physician control devices 2a, 2b may be configured to automatically modify one or more prescriptions if/when any of its analyses indicate that such modifications are likely to improve the efficacy of the prescription(s)) or responsive to user input.
  • Each of the physician control devices 2a, 2b may be configured to store one or more modified prescriptions in a database residing therein (e.g., a waveform database as described above) and/or to relay the modified thermal waveform(s) to the vestibular stimulation device la, lb, lc, Id with which it is associated.
  • the physician control devices 2a, 2b may be configured to transmit one or more modified prescriptions to the vestibular stimulation device la, lb, lc, Id with which it is associated over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • each of the vestibular stimulation devices la, lb, lc, Id may be configured to access a prescription database residing in the physician control device 2a, 2b with which it is associated and to retrieve the modified prescription(s) using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • the modified prescription(s) may be transferred to the vestibular stimulation devices la, lb, lc, Id using a portable memory device, such as an SD memory card or a USB memory stick.
  • Each of the vestibular stimulation devices la, lb, lc, Id may be configured to deliver one or more thermal waveforms to the vestibular system and/or the nervous system of the patient in accordance with one or more modified prescriptions to the vestibular system and/or the nervous system of a patient.
  • the vestibular stimulation device 1 may be configured to deliver the prescribed thermal waveform(s) the vestibular system and/or the nervous system of the patient by activating one or more TEDs to warm and/or cool an earpiece inserted into an ear canal of the patient.
  • the physician support device 4 may be configured to generate one or more software updates.
  • Each software update may comprise, consist essentially of or consist of a set of instructions for modifying one or more operational parameters one or more of the vestibular stimulation devices la, lb, lc, Id and/or one or more of the physician control devices 2a, 2b.
  • the physician support device 4 may be configured to store one or more software updates in a database residing therein and/or to relay one or more software updates to one or more of the vestibular stimulation devices la, lb, lc, Id and or one or more of the physician control devices 2a, 2b.
  • the physician support device 4 may be configured to transmit one or more software updates to the vestibular stimulation devices la, lb, lc, Id and or the physician control devices 2a, 2b over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • each of the vestibular stimulation devices la, lb, lc, Id and/or each of the physician control devices 2a, 2b may be configured to access a database residing in the physician support device 4 and to retrieve one or more software updates using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • one or more software updates may be transferred to the vestibular stimulation devices la, lb, lc, Id and/or the physician control devices 2a, 2b using a portable memory device, such as an SD memory card or a USB memory stick.
  • the software update(s) may be relayed from the physician support device 4 to the vestibular stimulation devices la, lb, lc, Id and/or the physician control devices 2a, 2b automatically (e.g., upon generation, once per week, once per month, etc.) or in response to user input.
  • Each of the physician control devices 2a, 2b may be configured to store one or more software updates in a database residing therein and/or transmit one or more software updates to one or more of the vestibular stimulation devices la, lb, lc, Id with which it is associated.
  • the physician control devices 2a, 2b may be configured to transmit the software update(s) to one or more of the vestibular stimulation devices la, lb, lc, Id with which it is associated over any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • each of the vestibular stimulation devices la, lb, lc, Id may be configured to access a database residing in the physician control device 2a, 2b with which it is associated and to retrieve one or more software updates using any suitable wired or wireless communications channel, including, but not limited to, a LAN, the Internet, a public telephone switching network, Bluetooth, WLAN and the like.
  • one or more software updates may be transferred to the vestibular stimulation devices la, lb, lc, Id using a portable memory device, such as an SD memory card or a USB memory stick.
  • Each of the physician control devices 2a, 2b may be configured to modify one or more of its operational parameters responsive to receiving and/or retrieving one or more software updates from the physician support device 4.
  • the physician control devices 2a, 2b may be configured to modify one or more of its operational parameters automatically ((e.g., upon receipt of the software update(s), once per week, once per month, etc.) or in response to user input.
  • Each of the vestibular stimulation devices la, lb, lc, Id may be configured to modify one or more of its operational parameters responsive to receiving and/or retrieving one or more software updates from the physician support device 4 and/or the physician control device 2a, 2b with which it is associated.
  • the vestibular stimulation devices la, lb, lc, Id may be configured to modify one or more of its operational parameters automatically ((e.g., upon receipt of the software update(s), once per week, once per month, etc.) or in response to user input.
  • the vestibular stimulation system comprises, consists essentially of or consists of a physician support device 4, a physician control device 2 and a vestibular stimulation device 1 comprising a controller 11, a pair of earpieces 12a, 12b, a pair of TEDs 13a, 13b and a pair of sensors 14a, 14b, wherein each of the TEDs 13a, 13b is operatively connected to the controller 11 via a thermal stimulation lead 16a, 16b and thermally connected to one of the earpieces 12a, 12b and wherein each of the sensors 14a, 14b is operatively connected to the controller 11 via a wireless connection 17a, 17b and thermally connected to one of the earpieces 12a, 12b.

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EP11849125.7A 2010-12-16 2011-12-16 Systeme, verfahren und vorrichtung zur abgabe von nervenstimulierungen an einen patienten unter ärztlicher aufsicht Ceased EP2651364A4 (de)

Applications Claiming Priority (14)

Application Number Priority Date Filing Date Title
US12/970,347 US8603152B2 (en) 2009-12-18 2010-12-16 Devices and methods for vestibular and/or cranial nerve stimulation
PCT/US2010/060764 WO2011075573A1 (en) 2009-12-18 2010-12-16 Devices and methods for vestibular and/or cranial nerve stimulation
PCT/US2010/060771 WO2011075574A1 (en) 2009-12-18 2010-12-16 Devices and methods for vestibular and/or cranial nerve stimulation
US12/970,312 US8460356B2 (en) 2009-12-18 2010-12-16 Devices and methods for vestibular and/or cranial nerve stimulation
US201061424326P 2010-12-17 2010-12-17
US201061424474P 2010-12-17 2010-12-17
US201061424132P 2010-12-17 2010-12-17
US201161497761P 2011-06-16 2011-06-16
US201161498096P 2011-06-17 2011-06-17
US201161498131P 2011-06-17 2011-06-17
US201161498080P 2011-06-17 2011-06-17
US201161498943P 2011-06-20 2011-06-20
US201161498911P 2011-06-20 2011-06-20
PCT/US2011/065456 WO2012083151A1 (en) 2010-12-16 2011-12-16 Systems, methods and apparatus for delivering nerve stimulation to a patient with physician oversight

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AU2011343589B2 (en) 2017-02-23
JP2018102934A (ja) 2018-07-05
AU2011343589A1 (en) 2013-06-20
EP2651364A4 (de) 2017-05-03
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CA2821262C (en) 2018-05-22
AU2011343564B2 (en) 2016-09-29
US20180008457A1 (en) 2018-01-11
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US20140243941A1 (en) 2014-08-28
US20130317576A1 (en) 2013-11-28
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US10660792B2 (en) 2020-05-26
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WO2012083151A1 (en) 2012-06-21
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US20120316625A1 (en) 2012-12-13
US9655772B2 (en) 2017-05-23
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